Sr.Executive- Quality Assurance in Pharma company
Posted on: 2010-12-30
SUPRIYA PRAVIN PATIL
CONTACT DETAILS: 9421976896/ 9423028154; e Mail: [email protected]
Objective: Seeking middle level assignments in Regulatory Affaires/ Quality Assurance/ Quality Control with a reputed organization in the Pharmaceutical Sector.
Strengths: With over 6.5 years of experience in Quality Control, Stability Study and Compliance Management have the deftness in handling stability study documents, quality system documents, regulatory documents, cGMP documents. Proven abilities in effectuating for preparedness of facing any time regulated audits. Effective communicator with excellent relationship management skills and possess a result oriented attitude with analytical skills. Currently serving as Sr.Executive – Quality Assurance with Siddharth Carbochem Products Ltd., Jalgaon.
Academic Profile: First Class Post Graduate in Biochemistry from Mooljee Jaitha College, Jalgaon affiliated to North Maharashtra University, Jalgaon (Maharashtra)-2004.
Additional Qualification:-
FDA approved for Chemical and Instrumental Analysis (subjected to Aurangabad jurisdiction).
Extra- Curricular Activities:-
1) Carried out project work on, “Surveillance of Diabetic Patients in Jalgaon City”, as a partial fulfillment for M.Sc. programme.
2) Conducted Seminar on, “Cryopreservation Techniques and its Applications”, as a partial fulfillment of M.Sc. programme.
3) Passed MS-CIT examination with 77% marks.
4) Passed ‘C’- Programming with ‘A’ grade.
Employment Scan:-
I) Sep-2010- till date Siddharth Carbochem Products Ltd., Jalgaon, Sr.Executive- QA
The company is diversified in manufacturing quality range of Bulk Drugs which include APIs like Aspirin, Methyl Salicylate, Amyl Salicylate, and Salicylic Acid.
The company is certified by ISO 9001: 2008 QMS, ISO 14001: 2004 EMS, ISO 18001: 2007 OHSAS, KOSHER and NSF.
Job Profile:
- Reviewing of analytical data of QC, Production, R & D and Stores.
- Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same.
- Responsible for GMP, GLP and Safety related documents.
- Preparation of Specifications, STPs & SOPs.
- Conducting Internal audits for compliance in House-Keeping, Safety and on-line documentation.
II) Feb-2010- Aug-2010 Wockhardt Biotech Park LTD, Aurangabad, Executive- QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in Aurangabad and rest of India, it sets up a 100% Export oriented Insulin & Erythropoietin API, Sterile and Formulation facility in Aurangabad to meet the requirement of its customers in USA, Russia, Columbia and other European markets. The company is certified with US-FDA, MHRA, TFDA, Colombia INVIMA & WHO-GMP. Also the company has its well equipped and modern R&D center in Aurangabad.
Job Profile:
- Analysis as well as documentation of API Bulk, Inprocess samples and Stability Products.
- Preparation, analysis as well as documentation of Working Standards.
- Reviewing of analytical data.
- Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same.
- Preparation Stability schedule, protocol and summery sheet.
- Responsible for GLP related documents.
- Preparation of Specifications, STPs & SOPs.
III) June - 2006 to Feb-2010 Orchid Chemicals & Pharmaceuticals Ltd. Jr.Executive-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at different locations in an around Aurangabad and Chennai, it sets up a 100% Export oriented Ultramodern API, Sterile and Granulation facility near Chennai to meet the requirement of its customers in USA, Australia, Africa, Canada, Japan and other European markets. The company is certified with US-FDA, MHRA, Danish Medical Agency, WHO-GMP, ISO 18001: 2007OHSAS and ISO14001:2004 Environment management Quality Certification,.
Job Profile:
- Analysis as well as documentation of Stability Products as well as Holding Time Study Products.
- Preparation, analysis as well as documentation of Working Standards.
- Up-gradation of Stability Study Summary Data Sheet as per Regulatory Affaires.
- Preparation & up gradation of Stability Calendar.
- Preparation of Stability documents as per US-FDA, MHRA & cGMP norms.
- Well familiar with SAP system (QM - Module).
- Daily monitoring of Temperature & Humidity of Stability Chambers [Make: - Newtronic Equipments; Software: - ICDAS Ver-2.1Data-Loggers].
- Partially working in Review / Compliance team, for review of Documents [Finished products, Reaction monitoring, IPQC docs, etc] and handling quality system documents like; OOS documents, Change Control, deviations, Laboratory investigations and OOT study in Stability studies.
- Preparation, Co-ordination and implementation of SOPs, specification, STP and various types of Formats related to SOP.
- Coordinating with R&D and PD Lab for Stability and Holding Time Study related issues.
- Coordinating with Regulatory Affaires and fulfilling their requirements with respect to filling of new drug products and annual updating.
IV) Dec- 2004 to June- 2006 Midas Care Pharmaceuticals Pvt Ltd., Aurangabad Sr.Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Aurangabad, it sets up an Export oriented Formulation facility and pioneer in Aerosol technology (MDI-preparations). The company is certified with MHRA, TFDA, and Brazil Anvisa.
Job Profile:
- Handled analysis and documentation of Raw Materials.
- Analysis and documentation of Bulk & Finished Products.
- Maintenance of Control Samples as per their storage condition and packing configuration.
- Maintenance of Chemical entry register & Glassware Calibration as well as record making.
- Analysis and documentation of on-going Stability of Finished products.
- Sound knowledge of Safety norms followed during handling of Lab chemicals and Steroids.
V) June- 2004 to Nov- 2004 JCPL Pharma Pvt.Ltd, MIDC, Jalgaon Officer-QC
A professionally managed fast growing Pharmaceutical Company having its manufacturing facilities at Jalgaon, it sets up an Export oriented Formulation facility. The company is certified with ISO: 9001 Quality Management System Certifications.
Job Profile:
- Chemical analysis of raw material as well as Intermediates and Finished Product.
- Handled Stability testing of Product.
- Preparation, Maintenance and Record keeping of volumetric solutions and other Laboratory Reagents.
- Instrumentation analysis of raw material and Product.
- Inventory control of lab chemicals and record keeping.
VI) May- June 2003 Blue Cross-Laboratories Pvt.Ltd, Nasik Inplant Trainee- QC
Job Profile:
- Chemical & Instrumental analysis of Raw material and Finished Products
- Basic Microbial Techniques.
Instruments Handled:
- H.P.L.C (Agilent 1100 and 1200 series) (Software: Chemstation)
- R.R.L.C (Agilent 1200 series) (Software: EZ-Chrome elite)
- H.P.L.C (WATERS 2650 series) (Software: Millenium2000 & Empowers2)
- H.P.L.C. (Shimadzu) (Software: Class-VP).
- Spectrophotometer (Perkin Elmer Lambda650 & Lambda25 & Cientra 10e)
- KF Autotitrator (Swiss made Metrohms)
- AAS (GBC 932 Plus) (Software: GBC Avanta)
- Rudolphs Autopol Polarimeter.
- Well versed with operating systems like Windows 2003 & Windows XP Professional and software packages like MS-Office Word & Excel.
Personal Skills:-
- Sincere, Self-motivated, hard working & capable of working in deadliness.
- Team player can motivate others to achieve objectives.
- Effective communicator can interact at all hierarchy levels effectively.
- Anxious to learn new things.
Languages known:-
Can speak & write fluently in English, Marathi and Hindi.
Personal Information:-
Address : - c/o Plot No. 8, ‘Kolhe Niwas’,
Behind ADCC Bank,
Prabhat Colony, Adalat road,
Aurangabad-431 001
Date of Birth : - 2nd April 1982
Marital Status : - Married
I declare that the information given above is true to the best of my knowledge.
Place: -
Date: -
(Patil Supriya Pravin)