Quality Assurance Manager
Resume:
SURESH. C
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Address: Dugar Homes, Tower # **, Door # 406, Kannagapattu, Thiruporur,
Kancheepuram District - 603 110, Tamilnadu, India.
E-mail: ************@*****.**.**
Mobile: +91-984*******, 984*******
Objective
Aim to be associated with a progressive organization, which offers me to
update my knowledge and to have a professional career in an organization
that ensures an excellent opportunity for continued professional growth.
Academic overview
M. Pharmacy Ist Class Dr. M.G.R. Medical University,
Chennai. 2003 - 2005.
B. Pharmacy Ist Class Annamalai University,
Chidambaram. 1998 - 2002.
Diploma in IInd Class IPER, Pune.
Pharmaceutical Quality 2002-2003.
Control and Quality
Assurance Management
Proficiency Profile Summary: 9 + Years of experience in Pharma Quality
Assurance.
CURRENT ORGANIZATION: VIVIMED LABS (ALATHUR) PVT. LTD., CHENNAI. AN USFDA
APPROVED PLANT. (Formerly known as Actavis Pharma).
Designation: Deputy Manager - Quality Assurance
Period : Since August 2011.
* Handling IPQA team and responsible for ensuring cGMP compliance in
shop floor.
* Planning and supervising day to day activities of IPQA.
* Batch Release and co-ordination with customers in final distribution
of finished goods by providing documents / data as required.
* Handling market complaints.
* Review and closure of investigations, incidents, deviations, OOS and
change controls.
* Monitoring the effectiveness of the CAPA.
* Initiate risk assessment at appropriate stages.
* Review and approval of process optimization, evaluation and validation
protocol and report.
* Review and approval of cleaning validation, production equipment
qualification protocols and report.
* Review and approval of Site Master File, Validation Master Plan and
Quality Manual.
* Review and approval of annual product quality review.
* Conducting periodical internal audits across all departments.
Achievements:
. Faced USFDA audit and completed successfully;
. Implemented quality risk management and for monitoring the effectiveness
of CAPA.
PREVIOUS ORGANIZATIONS:
DR. REDDY'S LABORATORIES LTD., HYDERABAD.
Designation: Assistant Manager - Developmental Quality Assurance
Period: April 2010 to August 2011.
* Review of product development reports.
* Handling customer complaints.
* Review and approval of Master Manufacturing and Packaging Records.
* Review and approval of stability protocols and reports.
* Review and closure of incidents, deviations, OOS and change controls.
* Monitoring optimization, exhibit and process validation batches.
* Preparation, review and approval of SOP's.
* Conducting periodical internal audits.
Achievements:
. Faced European audit and completed successfully.
. Implemented quality systems in CPS Formulations.
ACTAVIS PHARMA MANUFACTURING PVT. LTD, CHENNAI.
Designation: Senior Executive - Quality Assurance
Period: August 2007 to March 2010.
* Review of product development report, process optimization, exhibit
and scaleup batches, protocols, reports and batch records.
* Preparation of Process Validation Protocols and coordinating in
execution of validation activities and preparation of Process
Validation summary report for the products manufactured for various
regulatory markets.
* Monitoring Exhibit batches and Process validation batches.
* Preparation of cleaning Validation Protocols and coordinating in
execution of validation activities and preparation of summary report
of for the manufactured products.
* Preparation and review of SOP's.
ORCHID HEALTHCARE LTD., CHENNAI.
Designation: Executive - Quality Assurance
Period: November 2005 to August 2007.
* In-Process Quality Assurances activities in the manufacturing of
Tablets, Capsules and dry syrups.
* Monitoring exhibit batches, process validation and commercial batches.
* Review of Master and executed Batch Manufacturing and Packaging
records.
* Preparation of SOP's.
* Preparation of stability protocols and reports for evaluation.
* Preparation & Review of Annual product quality.
* Compilation of Vendor qualification reports.
* Periodical checking of Control samples and preparation of the reports
of their status.
Professional enhancement initiatives
External training programmes / Seminars undergone
* Chromatographic Analysis (Gas Chromatography) at Advanced Training
Institute, Government of India, Chennai.
* Participated in cGMP Training conducted by IDMA.
* Participated Training program on guidelines of 21 CFR Part 210 and 211
and UKMHRA.
* Cleaning validation, Insight systems Inc, Mumbai.
* Risk Management, Global Compliance.
Audits Exposure
* Faced USFDA audit in Actavis Pharma Mfg. Pvt. Ltd., Chennai.
* Active participation in various regulatory inspections (USFDA / UKMHRA
/ NSF / MCC / Uganda).
* Active participation in various customer audits (Glaxo,Cipla, Apotex,
NorthStar, Watson, Mutual Pharma).
Computer proficiency
* MS office,
* Excel
* Power point presentation
Skills
* Commitment to work.
* Creative and hard working.
* Excellent documentation skill.
* Good communication skills.
Personal details
Date of birth : 29 April, 1980
Nationality : Indian.
Marital status : Married.
No. of dependents : 2
Languages known : English, Malayalam, Telugu & Tamil.
Permanent Address : 68, Devanbu Street, Block - 30, Neyveli -
607 807, Cuddalore
District, Tamilnadu.
Passport details
Passport No. : K4268948
Date of issue : 26 / 07 /2012
Date of expiry : 25 / 07 / 2022
References : Mr. C. Umapathy, Senior Manager, Shasun
Pharmaceuticals.
Mr. Panjat Charam, General Manager, Ranbaxy Laboratories.
Declaration
I take this opportunity to introduce my candidature with correct and true
information as per my Knowledge.
Place:
Your's Sincerely,
Date:
C.SURESH.
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