Quality Control Assurance
Resume:
Permanent Address: **, Shreenath park Society, Nr. Vejalpur bus-stop, Vejalpur, Ahmedabad–380051. INDIA.
Mobile: 982-***-****, 999-***-**** Phone: (079-******** (R). E-mail: *********@*****.***
PROFESSIONAL EXPERIENCE:
Company: DISHMAN PHARMACEUTICALS & CHEMICALS LTD., AHMEDABAD.
(Approved by “USFDA, EDQM & TGA”, A Dishman Group of Co.)
Quality Control – In-charge (20/04/06 to onwards)
Responsible for Quality control function in the entire facility and Research and development activities.
Looking after Analytical Method Validations activities.
Looking after Cleaning Analytical Method Validations activities.
Looking after Analytical Method development activities.
Looking after Analytical Method Technology Transfer activities.
Looking after Primary, Working and Pharmacopoeial reference standards updation & maintenance.
Looking after LNB and Logbook writing, reviewing, approval and archiving.
Preparation of Protocol and Reports for Analytical Validation activities.
SOPs: Preparation, reviewing, maintaining, archiving and training.
Looking after preparation of Finished product related documents like Specification, STP, GTP, M.O.A., C.O.A. and pharmacopoeial updation.
Well Conversant with reviewing activity. Reviewing of Analytical Method Validation, Cleaning protocol and report; Specification, STP, GTP, M.O.A., C.O.A. etc.
Also looking after DQ, IQ, OQ, & PQ of Instruments.
Preparation and validation of Spreadsheets, preparation of different database.
Well Conversant with GXP and to ensure that Good laboratory practices are adhered to and QC personnel are trained on GLP.
Plan, oversee / carry out the Training and Development of all the laboratory personnel.
Arrangement of interdepartmental audits.
To participate in all validation and qualification processes.
Company: TORRENT REASERCH CENTRE, BHAT, Gandhinagar.
(A Torrent Group of Co.)
REASERCH SCIENTIST - II (ADL- Documentation) (07/02/05 to 18/04/06)
Preparation of Protocol and Reports for Analytical Method Validation.
SOP preparation, reviewing, maintaining, archiving and training.
Looking after preparation of finished product documents like Specification, STP, GTP, M.O.A., C.O.A. etc.
Also looking after preparation of Active & Inactive products documents like Specification, STP, and GTP etc.
Reviewing activity of AMV protocol and report, CVP & CVR, PVR, Specification and
STP, M.O.A. etc.
Also looking after IQ, OQ, & PQ and related documentation activity.
Preparation and validation of Spreadsheets, preparation of different database.
Data searching and recording in SAP system.
Well Conversant with cGMP & cGLP.
Company: ZYDUS CADILA HEALTHCARE LIMITED, ANKLESHWAR.
(A “USFDA”, “EDQM” approved, Zydus Group of Co.)
Sr. CHEMIST (Validation Cell) (26/12/03 to 05/02/05)
Analytical Method Validation of API by HPLC and GC.
Cleaning validation of API and Intermediates by HPLC.
Forced Degradation of API by HPLC.
Preparation of Protocol and Reports for method validation as per DMF requirement.
Method Development of API and Intermediates by HPLC and GC.
Also looking after Trouble shooting of Instruments.
Looking after requirements: Chemicals, Glassware, PVC ware, laboratory
Equipments & spares.
Also looking after IQ, OQ, & PQ of different instruments.
Well Conversant with cGMP & cGLP.
Well accustomed with highly sophisticated Instruments:
Company: TONIRA PHARMA LIMITED, ANKLESHWAR.
(An “EDQM”, “WHO” & ISO 9002 approved, Tonira Group of Co.)
Q.C. CHEMIST (Quality Control) (01/10/99 to 24/12/03)
Analysis: Raw material, Intermediates & Finished product etc. & Quality Assurance
of Finished Product and Packaging.
Stability Study, Method Validation.
Well Conversant with cGMP & cGLP.
Looked after requirements: Chemicals, Glassware, PVC ware and other laboratory
Equipments.
Volumetric solution preparation and Standardization, Instrument Calibration etc.
Company: ARTEK ORGANICS IND. (P) LTD., PANOLI.
TRAINEE CHEMIST (Quality Control) (06/06/99 to 13/09/99)
Analysis: Raw material, Intermediates & Finished product etc. & Quality Assurance
of Finished Product and Packaging.
Volumetric solution preparation and Standardization, Instrument Calibration etc.
Well accustomed with highly sophisticated Instruments:
INSTRUMENT PROFICIENCY:
HPLC : Waters, Perkin Elmer, Shimadzu, Agilent, Dionex etc.
Ion-Chromatography : Dionex.
GC/HS : Perkin Elmer, Agilent, Chemito, Netel etc.
Autotitrator : Mettler etc.
Spectrophotometer : Chemito (UV 2600), Shimadzu etc.
Karl-Fischer Instrument : Ana Link & Vego Matic.
M.P. / B.P. Apparatus : Scentific, Ana Link etc.
Polari-meter : Rajdhani Scientific etc.
VOCATIONAL TRANING:
2 days Vocational Training on “Analytical Method Development and Validation” by Waters India.
2 days Vocational Training on “Cleaning Validation” by Prescription Pharma support.
ADDITIONAL QUALITIES:
Positive Attitude & Thinking, Visualization Power, Enthusiastic to learn new things.
SUMMARY OF QUALIFICATION:
Passed S.S.C from G.S.E.B. with First class (63.0 %) in March ‘1994.
Passed H.S.C. from G.S.E.B. with Second class (53.0 %) in March ‘1996.
Passed B. Sc. (Chemistry) from South Gujarat University, Surat. with Higher second class (59.0 %) in April ‘1999.
Completed M. Sc. (Chemistry) from Madurai Kamraj University, Madurai. with higher second class (56.0 %) April ‘2007.
Passed B. LI. Sc (Lib. & Inf. Sc.) from South Gujarat University, Surat
with second class (52.0 %) in April ‘ 2003.
Passed C. I.C. from IGNOU with First class (61.5 %) in December ‘99.
Passed Certificate course in Windows & MS-Office from I.T.I, Guj. Government in June ‘2000.
Passed Certificate course in C & C++ from I.T.I, Guj. Government in
August ‘2000.
Computer Skills Operating Systems: DOS, Windows 95/98
Packages: MS-Office, C & C++
Languages English, Gujarati, Hindi.
Hobbies Chemistry, Cricket, Music.
Strengths Good communication skills, Team spirit, positive mental attitude & punctuality.
Personal Date of Birth : 14th OCTOBER 1978.
Details Marital Status : Married
Blood Group : B+ve
Passport No. K0902445 / 16-10-2021
/Expiry:
Salary Drown 7.11 lackh (Gross P.A.)
Salary Expected Negotiable
Reference (i) Mr. T I Dalwadi – GM – Quality Control (Dishman)
Mobile – 987**-*****
DATE: DIVYESH D. THAKKAR
Contact this candidate