Quality Assurance Manager
Resume:
T.G.Murali
M.Sc.,M.Phil
#****/* *** ***** * rdfloor
JANAPRIYA HEAVENS
Allalasandra G.K.V.K.Post
Bangalore-560065.
To
Respected Sir
Sub: Post of
applications called for
regarding. Date on:
I submit my application for the favour of your kind consideration of my
candidature for the above said post in your esteemed organization. My
qualification and experience are as follows. I passed M.sc., M.Phil,
(Ind.Chemistry) in July 1992 in first class and secured 73% of marks. I
worked in a reputed pharma industry for their manufacturing units
conforming to cGMP and WHO standards situated in M/S. Anglo-French drugs
and Ind. limited peenya Bangalore-560058(Formulation Plant) fromFeb.1995 to
July2006 as Sr.Executive Quality assurance and till date have put rich
experience in the post in quality assurance department.
I am having sufficient experience in manufacturing pharma tablets,
capsules, Liquid orals, Sugar coating, Enteric coating, Film-coating,Dry
powder syrup, Dry powder Injection(Sterile),Liquid injection(Sterile),etc.,
along with maintaining documentation required for cGMP concepts defined by
US-FDA,MHRA-UK,
TGA-Australia, MCC- South Africa,WHO and EU guidelines.
I am FDA approval QC/QA executive in chemical instrumental analysis of
drugs, writing SOPs, master formula, validation documents and computer
literate.
I worked as Assistant Manager Quality assurance (Formulation) at M/S.
CADILA PHARMA DHOLKA AHMEDABAD from July2006 to July 2007. Cadila pharma
has the approval of regulatory authorities like MHRA, TGA, MCC, WHO. I am
having relevant experience in formulation plant with exposure to In process
control (IPQA), process validation, equipment qualification and regulatory
audits, Manpower planning and monitoring of granulation, compression,
Liquid-orals, coating, parentral manufacturing, Dry powder orals, Dry
powder injection etc.,
I was working as Manager Quality assurance M/S.AUROBINDO pharma Ltd
Hyderabad. With approved by USFDA, WHO, MCC-SA and ANVISA-Brazil both
formulation. I was working from July 2007 to Feb.2010.
I was working as Deputy General Manager Quality Assurance division at
M/S.Choksi laboratory Ltd., Indore 452001 FDA and USFDA approved analytical
laboratory for pharma drugs products testing from Feb.2010 to June.2012.
At, present I am working as Assistant general manager quality assurance at
M/S. Medo- pharma Ltd Bangalore from July 2012 Onward. A vide copy of
resume with necessary details are enclosed for your reference. Assuring my
faithful service if appointed, thanking you and awaiting the favour of an
early reply
Place:
Yours truly
Date :
(T.G.MURALI)
T. G. Murali
4035/B, 4th Block 3rd Floor, Janapriya Heavens
Ph: +91-984*******, +91-973*******
Allalasandra, G.K.V.K.
Post Bangalore - 560065.
Email:acemtj@r.postjobfree.com &acemtj@r.postjobfree.com
OBJECTIVE:
Seeking assignments in SR. Quality Assurance Manager or Head quality
Assurance or VP quality assurance top management with a growth driven
organisation of repute.
Professional Summary
Seasoned professional with 22 years, of rich and insightful experience in
Quality Assurance department (Formulation), in reputed pharma concern
spearheading efforts to accomplish corporate objectives of M/s Anglo French
Drugs Industry Ltd, Bangalore-560 065 as SR.Quality Assurance Executive
(formulation), from Feb.1995 to July.2006. M/S. Cadila Pharmaceuticals Ltd
Dholka-387810 as Assistant Manager Quality Assurance (formulation), from
July.2006 to July.2007. I worked as Manager Quality Assurance
(formulation) M/S.AUROBINDO Pharma Ltd Hyderabad from July2007 to Feb.2010.
I was working as Deputy General Manager Quality Assurance at M/S Choksi
laboratory Limited Indore-452 001(USFDA &FDA approved analytical
Laboratory) fromFeb.2010 to Jan.2012.
At present I am working as Assistant General Manager quality Assurance at
M/S. Medo-Pharma Ltd. Bangalore from July.2012 onwards.
Proven technical skills in:
- Checking Schedule M, cGMP, GLP, FDA, USFDA, EU, as requirement.
- Standard operating procedure.
- Document control, Product recall procedures & specification
procedures.
- Process Validation, Cleaning validation, Change control procedures
and deviation.
- BMR/BPR Issue, Safety measures mix up, Cross contamination.
- Recording BMR and BPR review & release to market.
- Deviation control & Handling labeling procedures.
- Cleaning procedures & Fumigation of area, Pest and rodent control.
- Handling Market compliant, & Humidity and differential pressure
monitoring (BMS-system).
- Water system, HVAC system & Vendor Audit.
- Distinction in calibration and operation equipments.
- Training of all staff (technical & Non technical) cGMP training,
SOP training, GLP training, Induction training, related to quality aspects.
- System compliance as per cGMP & GLP.
- Investigating product complaints.
- Implementation Quality System.
- Review & approval of quality manual, site Master file, Validation
Master plan, DMF,CAPA,SOP,Risk- management analysis and implementation,
procedures, Specification and Validation protocol etc.,
- Correspondence with customer market partners, manufacturer, Supplier
related to entire quality aspects.
-validation techniques (Process), Vendor Audit, Standard test procedure
specification procedures, Calibration Spectro-photometer UV, florimeter, DT
apparatus, Hardness apparatus etc, with a key focus to customer
satisfaction and optimum results.
-Skilled in instrumentation U-V spectrometer, atomic spectrometer,
operation HPLC and calibration as per GLP requirement.
-Stupendous communication skills, honed with the ability to liaise with all
the levels of the management.
-CGmp/WHO audit, MHRA audit, TGA audit and US-FDA audit.
-Good documentation and documentary support is given to Regulatory
department for registration for new product around the globe.
-Oversee equipment, facility, method and product validation activities for
compliance and self inspection.
-Assist QA director in development of quality system.
Ensure appropriate change control processes are in place and being followed
as per cGMP.
-Handling of audits like USFDA, MHRA, TGA, ISO, FDA, WHO, UNICEF, MCC-SA
and ANVISA-Brazil EU audit etc., and various customer inspections.
ORGANIZATION SCAN
1. M/S.ANGLO-FRENCH DRUGS LTD. PEENYA SECOND STAGE BANGAORE-560058 (cGMP,
WHO and FDA approved plant)
JOB SKILL IN DETAILS
Since Feb.1995 to July2006 M/s Anglo French Drugs & Industry Ltd, Bangalore-
560058 as SR.Quality Assurance Executive (formulation Plant). I am having
good knowledge and hands on experience in quality Assurance activities in
the plant, developing protocols for process validation, cleaning
validation, In-process control and handling inspection/ audits by
international regulatory agencies, water -system, HVAC-system, Handling
market compliant and investigating, BMR& BPR review and release, Raw-
material- flow chart, Man- movement- flow chart, ISO- clean room
classification & Humidity and differential pressure monitoring, technical
drawing, etc.,
The Growth Path:
Appointed as Trainee Junior Executive in Mar'95.
Promoted as Assistant Executive in Mar'98.
Promoted as Senior Executive - QA/ QC in Mar'02.
2. M/S.CADILA PHARMACEUTICALS LTD. TRASAD DHOLKA AHMADABAD-387 810. (MHRA,
TGA, MCC AND WHO APPROVED FORMULATION PLANT)
I worked as Assistant Manager Quality assurance (Formulation) from July
2006 to July 2007.
Company profiles
M/S.Cadila pharmaceuticals limited trasad Road Dholka-387810 is a fast
growing multilocational company (600cr) in Indian market& regulatory
market. Cadila exports wide range of products in various countries in
world. The company manufactures single dosage forms (Tablets, Capusules,
&Liquid injection) and multi dosage forms (Dry-powder injection, Dry-powder
Orals & Liquid Orals) Lyophilizer, &APIcrystillation technique.
Cadila pharma has the approval of different regulatory authorities like
MHRA, TGA, MCC, WHO, and audit by Africa, CIS, Japan and USA Row countries
other regulatory agency.
JOB SKILL IN DETAILS
Supervised all activities of in-process controls and monitoring in shop
floor activity and maintained CGMP/WHO/MHRA, TGA audit for good
documentation and regulatory requirement.
-Modified protocol as per regulatory requirement for implementation Quality
System.
-Changing and maintaining the documents related to change control
procedures as per cGMP.
-To ensure system designing, rotator, compliance &audit preparation along
with the co-ordination with various department.
-Final products release to market distribution both BPR and BMR records
checked.
GMP coordination and team member for self-inspection audit.
-Preparation of validation protocols &execution of all validation programs
like process validation (Prospective, Concurrent, retrospective,
revalidation) & cleaning Validation.
-Vendor development and vendor audit for critical starting materials and
packing materials.
-Audit/Review the cGMP compliance in many pharmaceuticals industry for
contract manufacturing
-Calibration programmed as per schedule
-Doing equipment qualification (IQ, OQ&PQ) and water system, AHU &HVAC
system validation.
-Motivated and lead of QA officer for proper documentation and
cGMPtraining, SOP training, Induction training.
-Ensure effective implementation of system and procedure as per cGMP, GLP
&ISO and other regulatory requirement.
-Review & approval of quality manual, Site Master File, Validation Master
Plan,BMR,BPR, procedures & validation protocol etc.,
-Review final SOP & Monitoring cGMP documentation.
-Handling deviation, change control, incident report, non-conformance, DMF,
SOP preparation, Technology transfer, ICH guidelines.
-Risk management, CAPA,
-Creation of quality systems and procedures.
-Handling of market complaints, deviation and product failures.
-Identifying needs & providing training for technical staff.
-Evolution of corporate quality policy.
-APR study for various products.
3. M/S.AUROBINDO PHARMA LTD HYDERABAD. (USFDA, UKMHRA, ANVISA BRAZIL, EU
AND WHO APPROVED (FORMULATION PLANTAND API)
COMPANY PROFILE
Among the largest 'Vertically Integrated' pharmaceutical companies in
India, Aurobindo has robust product portfolio spread over major product
areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics,
Gastroenterological, Anti-Diabetics and Anti-Allergic with approved
manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil and
EU audit for both APIs & Formulations and has Global presence with own
infrastructure, strategic alliances, subsidiaries & joint ventures.
I was working as Manager Quality assurance M/S.AUROBINDO PHARMA Ltd
Hyderabad. From july2007 to Feb.2010.M/S.Aurobindo pharmaceutical company
(2500Cr) in Indian & regulatory US market.Aurobindo exports wide range of
products to US, Europe, ROW, Brazil, market respectively. The company
manufactures single dosage forms (Tablets, Capsules, Orals &injection) and
multi dosage forms (Dry-powder injection& Dry powder syrups), Sterile API,
Lyophilizer, &APIcrystillation technique.
JOB SKILL IN DETAILS
(Total no. of person handled: 30).
-Supervised all activities of in-process controls IPQA activities and
monitoring in shop floor in Dry-powder injection( Sterile), Dry powder
syrup, Tablets, capsules, sterile API, Lyophilizer & API crystillation.
-CGMP practice, WHO, US-FDA, TGA, ANIVISA-Brazil and ensure the
compliances.
-Checking schedule M, cGMP, USFDA, ICH, EU guidelines as requirements.
- Preparation Standard Operating Procedure. & Vendor Audit.
-Document control - Deviation Control & change control and CAPA and
incident report.
-Authorizing batch approval (BMR & BPR) issue for sterile, oral Tablet,
capsules, & review release dispatch for regulatory market only.
-Investigating market complaint in shop floor for sterile & oral
department respectively.
-Modified protocol as per regulatory requirements for implementation
quality system.
-Correspondence with Customers marketing partner's manufacturer, supplier
related to entire quality aspects.
-Training of all staff related to quality aspects & cGMP coordination and
team member for self- inspection audit.
-Preparation of validation protocols & execution of all validation programs
like process validation (prospective validation, Retrospective validation,
concurrent validation& Revalidation) and cleaning validation, Site Master
File.
-Validation Master plan, DMF, GMP& ISO and other regulatory requirement.
-to ensure system designing implementation, compliance & audit preparation
with various departments.
-Maintain documentation as per WHO/FDA/EU/ICH guide-lines.
-Trouble shooting the shop floor activities.
-Ensuring calibration program as per schedule.
-Sound data are developed by process development to determine the process
capability and optimize the overall process.
-Providing effective training in QA tool like Statistical Process Control &
Total Quality Management to team member.
- Guiding process validation, equipment qualification, water system, HVAC
system, BMS systems, technical flow charts like material movement, man-
movement, ISO clean room classification, AHU as per regulatory
requirement.
-The validating and monitoring Aseptic Fill area and process validation of
Solid oral dosage form.
-Facility up-gradation co-coordinating DMF filling in US and regulatory
support for export requirement and registration around globe.
-APR study for various products.
-Risk management, non-conformance, sitemasterfile, and DMF and quality
system.
4. M/S.CHOKSI LABORATORY LTD. INDORE 452001. (USFDA & FDA APPROVED
ANALYTICAL LAB, NABLAPPROVED, BIS, NAL, ISO/IEC17025TESTING/CALIBARATION,
ISO/1400)
I was working as Deputy General Manager Quality Assurance division at
M/S.Choksi laboratory Ltd., Indore 452001 FDA and USFDA approved laboratory
pharma drugs products testing. I worked from Feb.2010 to JUN.2012
JOB SKILL IN DETAILS
(Total no. of person handled: 10).
-Checking GLP, FDA, USFDA, &ICH guidelines as requirements.
-Preparation Standard Operating Procedure. & Vendor Audit.
-Document control - Deviation Control & change control and CAPA.
-
-Investigating market complaint as per customer.
-Modified protocol as per regulatory requirements for implementation
quality system.
-Correspondence with Customers marketing partner's manufacturer, supplier
related to entire quality aspects.
-Training of all staff related to quality aspects & cGLP coordination and
team member for self- inspection audit, internal audit, Change control,
Deviation control.
-Preparation quality manual, handling non-conformance, incident report
etc.,
Preparation Site Master File.
-Validation GLP& ISO (Management system manual and management system
procedures) and other regulatory requirement.
-to ensure system designing implementation, compliance & audit preparation
with
Various departments. (FDA, USFDA, NABL calibration etc.,)
-Calibrations of equipment in quality control, self inspection, equipment
qualification and etc.
-training ICH, USFDA guidelines
-ISO/IEC17025 testing/calibrations, NABL, BIS and microbiology testing.
-water system and HVAC system.
5. M/S.MEDOPHARM NO.34-B INDUSTRIAL AREA, PHASE II, MALUR-563 130 KOLAR
DISTRICT KARNATAKA (cGMP, WHO, FDA APPROVED, UNICEF, IDA NETHERLANDS, TROGE
(GERMANY), DENMARK, PILCO, AMSTEL PHARMA AND ROW COUNTRIES)
At present I was working as AGM-QUALITY ASSURANCE at M/S.Medopharm malur
kolar district Karnataka from July.2012 onward.
JOB SKILL IN DETAILS
(Total no. of person handled: 25).
I am having good knowledge of In-process checking (IPQA) Market compliant
handling, Non-conformance, Quality system. DMF, Site master file, deviation
control, change control, Audit compliance, ISO system, CAPA, Risk
management, SOP, Technology Transfer, Process validation, Training cGMP,
ICH guide lines training, FDA training, SOP training, cleaning validation,
Batch manufacturing records, batch packing records, HVAC system, water
system, good knowledge in tablets, capsules, self inspection, APQR,out of
specification,recall procedure,calibration,Validation master plan,UNICEF
audit, MEG (srilanka), IDA Netherlands, Troge (Germany), Denmark, Kenya
audit, Malvi,amstel pharma ROW market and etc.,
Operations:
Instrumental in Tablets manufacturing, liquid manufacturing involving
authorization of batch manufacturing record for various products.
Overseeing adherence to SOP, master formulae, validation documents, review
of batch manufacturing records.
Validation documents (Process), equipment validation DQ, IQ, PQ, and OQ,
Validation of cleaning procedure, calibration of compound vessel,
accessories, utensils and stirrers.
In-process control (IPQA) for tablets and capsules, operation and cleaning
or filter press, cleaning validation of compounding tank, D.M .water plant
regeneration.
Line clearance activity in tablet packing department and liquid-
department.
Products identification, packing- profile, leak-test, in-process checking,
BPR review, yield reconciliation, and packing techniques.
The Noteworthy Milestones:
Played instrumental role in improving the quality of the product through
critical checking in the in-process stage by quality assurance activity.
Distinction in slashing down market-complaint and completely negating
complaint from export products.
Drove efficient efforts for preparing QA fortnightly report to General
ManagerQA.
QUALITY ASSURANCE CO-ORDINATION WITH FORMULATION DEVEOPMENT DEPARTMENT
(FR&D) FOR TECHNOLOGY TRANSFER
- Checking the new formula validation batch carried out for pilot scale
manufacturing (Transfer of technology) carefully checking all stages and
approving specification for tablet, Liquid, herbal formulation, and various
products for commercialization.
Other Assignments
1. Aug'93 - Mar'95 Chamber of Commerce, Manali Ramakrishna Polytechnic
Asst. Lecturer (Chemistry).
2. July1992-Apr1993 - Little Flower School & Junior College Lecturer
(Chemistry).
Teaching & tutoring on Chemistry as per academic curriculum to students.
Recognizing, respecting & nurturing the creative potential of each student.
Responding to all classroom queries in a spontaneous manner.
Accountable for fostering a healthy learning atmosphere in class.
Professional Enhancements (TRAINING)
1. Attended WHO/CGMP guidelines and ISO. Guidelines by R.S. Iyer & Saranga
Iyer. (GSK INDIA LIMITED)
2. Attended WHO/CGMP guidelines Programmed by Pettkar Vjjcoal - prabla
consultants. (BLUE-CROSS LABORATORIES)
3. Trained in "Safety Programmed" & first aid Programmer provided by
company. (St.Jhons Red Cross society)
4. Trained in "Management Programmed" "Time Management" and "Executive
development Programmer" provided by company. (Dr.Kannan)
5. Solid dosage training advanced cadpress & advanced coating process and
troubleshooting programmed by (Mr. Fred Rowley US)
6. Training attended for Total quality Management, STATISTICAL PROCESS
CONTROL, ETC.,
7. ITS Skills
-Computer Training in MS Office from Training Institute of M/s Anglo French
Drugs & Industry Ltd. Bangalore 560058.
8. I attended the training programmed on laboratory quality management and
internal audit as per ISO/IEC17025 held during 05-08 April2010 at NITS
Nodia conducted by National Institute of training for Standardization,
Bureau of Indian Standards.
Academic Project (M.SC., IND. CHEMISTRY)
Jan'92- Jun'92 Bharat heavy electrical Limited TRICHY- (TN)
Evaluation of Alloying Elements in Low Alloy Steel by Emission (Metal)
Spectroscopic Technique. (GERMANY TECHNOLOGY)
Academic Credentials
Sl. Name and address University/ Degree/ Specialisati Percentage Year of
No. of Diploma on Class/Rank Passing
Institution/colleg Board
e/
School
1 Blake higher Board of SSLC English, 69.2% APR.1984
secondary school secondary Tamil, (First
Thanjavur education Math, class)
(Regular) Science &
History
&geography
2. Blake higher Board of HSC English, 62% APR.1986
secondary school Higher (First-grou Physics, (First
Thanjavur secondary p) Chemistry,& class)
(Regular) education Math
3. Raja Serfoji Bharathisda B.Sc., Chemistry, 63% APR.1989
govt.college san Chemistry Physics & (First
Thanjavur University Math class)
(Regular)
4. AVVM Sri-pushpam Bharathisda M.Sc., Organic 73% July.1992
college san Chemistry Inorganic (First
Thanjavur(Regular) university Physical Class)
chemistry
and
Analytical
chemistry
5. Annamalai Annamalai B.Ed., Chemistry 58.50% May.1994
University University (Chemistry)
6. Prist university Prist M.Phil Chemistry 73.0% March.
university Chemistry 2012
Personal dossier
Marital : Married
Languages known : English, Tamil, Telugu, Kannada and Hindi
E-mail :acemtj@r.postjobfree.com &
acemtj@r.postjobfree.com
Phone no : 098******** and 973-***-****
Date of Birth : 28th October, 1966
Permanent address :No.4035/B 4th Block 3rd floor Janapriya
heavens
Allalasandra GKVK post
Bangalore560065.
Family details given below:
Name Relationship Date of Occupation/ Position/
Birth Employer Designation
G.Radhika Wife 25.10.1971 House wife Nil
M.Aishwarya Daughter 28.11.1998 Studying 9th STD Nil
G.Bama Mother 1.02.1934 Late Nil
T.K .Govindaraj father 1921 Late Nil
T.G.Ravi Brother 19.02.1961 Not working Nil
Reference: 1
1. M.S.Revankar M.sc.,
General Manager QC/QA
M/S.Anglo-french Drugs &Ind.Ltd.
Bangalore-5600058
Tel: 080-********
E-Mail: quality acemtj@r.postjobfree.com
Reference.2
2 Mr.B.L.Balasubramanyam
Senior executive quality Assurance
No.30 I Floor 6th E main second stage, II phase, west of chord Road
Mahalakshmi layout Bangalore560086, mobile no. 099********,
acemtj@r.postjobfree.com
Reference: 03
3. Dr.A. Mohan Ph.d
General Manager quality control (R&D)
M/S.Lupin Pharma Ltd Pune
Tel No. 976-***-****
E-Mail: acemtj@r.postjobfree.com
Strength in work
I am possessing
-Good leader-ship qualities, work Ethics, and Decision making.
-Communication skill
-Human relation
-Positive Attitudes
-Planning
- Promptness and training of sub-ordinates toward workgroup
Extra-Curricular activities
Participated in games like cricket, foot-ball, chess etc, .I was
participated in quiz programmed in school and college level. Reading books,
magazine, scientific books etc.,
Declaration
I here by declare the entire above mentioned are true and correct to my
best of my knowledge and belief.
Place:
Yours truly
Date:
(T.G.Murali)
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