Manager
Resume:
Curriculum Vitae
MASUTHI PALLAM IST STREET,
SAIDAPET,
CHENNAI – 600 015,
TAMIL NADU,
INDIA.
MOBILE NO. : +91-934*******
E-MAIL ID.:**************@*****.***
***********@*****.***
PERSONAL PROFILE :
NAME : K.BASULUDEEN
DATE OF BIRTH : 07/06/1979
MARRIAL STATUS : MARRIED
PLACE OF BIRTH : CHENNAI
EDUCATIONAL QUALIFICATION (DEGREE) :
Name of the COLLEGE : THE NEW COLLEGE
Name of the UNIVERSITY : UNIVERSITY OF MADRAS
Name of the DEGREE : B.Sc CHEMISTRY
CLASS OBTAINED : Ist CLASS
Name of the DEGREE : M.Sc CHEMISTRY
CLASS OBTAINED : IInd CLASS
EDUCATIONAL QUALIFICATION (DIPLOMA):
Name of the COURSE : CERTIFICATE IN COMPUTING (CIC)
Name of the UNIVERSITY : IGNOU
Name of the COURSE : POST GRADUATE DIPLAMA IN COMPUTER APPLICATION
(PGDCA)
Name of the INSTITUTE : GLYNSIS SOFTWARE
Name of the COURSE : TYPE WRITING (ENGLISH-LOWER)
Name of the INSTITUTE : INSTITUTE OF TECHNICAL EDUCATION, TAMIL NADU.
Total years OF EXPERIENCE : 15 Years and 03 months in QC
JOB PROFILE: (Previous Employers)
NAME OF THE COMPANY: PROVENTUS LIFESCIENCE LIMITED
MARAIMALAI NAGAR
KANCHEEPURAM DISTRICT
TAMIL NADU
INDIA
Current Designation : DEPUTY MANAGER QC (PHARMA INDUSTRY)
CURRENT CTC : 8.0 LAKSHS P.A
PERIOD: Dec-2018 To Jun-2019
Job Responsibilities:
Head – Quality Control
1.To participate in the audits (internal and external) and make the system for its compliance.
2.Responsible for handling of customer complaints, returned products and OOS investigation, deviation and Lab incidents investigation within the time frame.
3.To prepare the audit response and CAPA within the time frame.
4.Handling of QC team (7 Persons) and get the maximum output and release the batch report on time with reliable results.
5.Preparation and approval of proper planning schedule for people and activities.
6.To verify the calibration of analytical instruments as per schedule and their documentation.
7.Monitoring the operation of analytical instruments as per laid down procedures.
8.To verify the Purified Water analysis (for both chemical and microbial) and its documentation.
9.Review the analytical data’s along with audit trails.
10.Responsible for trouble shooting in all lab instrument and resolve the issue within the time frame.
11.To verify the Preparation of Reagents, Volumetric Solutions, pH Buffer Solutions followed by proper labeling and their documentation.
12.Verification and approval of sampling, analysis and clearance of raw materials, in-process, Intermediate and Finished products and its documentation.
13.Review of SOP’s, specifications, method of analysis (MOA) and follow up of GLP & cGMP practices.
14.Monitoring and verification for maintaining a good lab atmosphere in working area and as well as maintaining a good office atmosphere.
15.Identifying the source for the reported errors and deviations and their rectification.
16.Follow up of raised work orders to Maintenance department and their proper rectification.
17.Review of change control system, changes if any.
18.Approval of COAs and issuance of Printed Finished Product Label.
19.To maintain, verify and plan the analysis of stability schedules for all the products and their proper documentation review.
20.To maintain the control samples for all products and for salable intermediates and their documentation.
21.Giving training to fresher, subordinates on SOP’s, ON JOB, Etc., and its documentation.
22.Monitoring of IQ, OQ and PQ for new lab equipment and annual calibration/validations.
23.Responsible for AMC of all the critical analytical instruments and equipments.
24.Responsible for all Preparation of Working Standards and maintenance of Reference standards.
25.Responsible for HPLC/GC Column management.
26.Responsible for providing samples to customers and its documentation
27.Responsible for reporting and recording of all deviations and incidents.
28.Responsible for making monthly indents for lab chemicals, glassware, Chromatographic analytical columns and Certified Reference standards.
29.Responsible for sending sample to outside lab and continuous result follow ups and release the COA.
30.Responsible for safety follow ups in QC lab.
ADL Responsibilities:
1.Responsible for Analytical Method feasibility, Method Development and Method validation of new products as per in-house method.
2.Analytical verification for new products as per pharmacopeia method.
3.To review the Method development, Validation and verification documents as per requirement.
Commercial Software known:
1.LIMS
2.SAP
Instrument software known:
1.Waters – Empower2
2.Schimadzu – LC solution
3.Open lab
4.UV probe
5.Metrohm’s
6.Perkin Elmer – Total chrom Navigator
7.Agilent – Chemstore
Lab procurement Responsibilities:
1.To identify the local vendor for lab chemicals and spares for the lab instruments.
2.Qualify the vendor as per norm.
3.To perform the vendor audit.
4.To perform the outside lab audit.
5.To do the negotiation against the quotation.
6.To follow up the P.O. to get material on time.
Lab Safety responsibilities:
1.To ensure the safety aspects in the laboratory.
2.Report the incident to management happened in the lab.
3.To ensure all chemists has to wear PPE’s and follow safety measure.
4.Segregassion of Chemicals (Hazardous, poisonous) as per safety chart.
5.To provide first aider and safety training to lab chemists.
NAME OF THE COMPANY: ALCHYMARS ICM SM PRIVATE LIMITED
(USFDA UNIT)
SIDCO INDUSTRIAL ESTATE
ALATHUR (NEAR CHENNAI)
Designation : ASSISTANT MANAGER QC (PHARMA INDUSTRY)
PERIOD: Jun-2018 To Sep-2018
NAME OF THE COMPANY: SGS INDIA PRIVATE LIMITED
(USFDA UNIT)
TARAMANI, CHENNAI
Designation : EXECUTIVE QC (PHARMA INDUSTRY)
PERIOD: Dec-2016 To June-2018
NAME OF THE COMPANY: ORCHID CHEMICALS & PHARMACEUTICALS LIMITED
(USFDA & UKMHRA UNIT)
SIDCO INDUSTRIAL ESTATE
ALATHUR (NEAR CHENNAI)
Designation : JUNIOR EXECUTIVE QC (PHARMA INDUSTRY)
PERIOD: March-2007 To April-2016
NAME OF THE COMPANY: NICHOLAS PIRAMAL INDIA LIMITED
(API & FORMULATION UNIT)
ENNORE
CHENNAI
Designation : EXECUTIVE QC (PHARMA INDUSTRY)
PERIOD: Feb-2004 To March-2007
LANGUAGES KNOWN:
ENGLISH - SPEAKING, WRITING, READING
TAMIL - SPEAKING, WRITING, READING
URDU - SPEAKING
HINDHI - SPEAKING
Declaration:
I hereby informed to you that the above said details are true and best of my knowledge.
Your’s sincerely,
Date :
Place :
(K.BASULUDEEN)
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