Reg Affairs Associate

VIVEK K. PATEL

** ****** ****, *** **, Edison, NJ 08837 516-***-**** qu6ut2@r.postjobfree.com

OBJECTIVE

Aim to be associated with a progressive organization that gives the scope to apply my knowledge and skills and to be part of the team that dynamically works towards the growth of the organization.

SUMMARY

Self-motivated, detail-oriented and experienced Quality Assurance/Regulatory Affairs professional with strong multi-tasking and organizational skills and proven ability to supervise 28 workers/10 operators. Background includes work experience in Packaging, Manufacturing, Quality Assurance and Regulatory Affairs department in Pharmaceutical industry. Have taken on increasing responsibilities based on performance and recognized for quick learning, troubleshooting, adaptability, problem solving and negotiation skills. Work well individually with little supervision and contribute effectively to develop a strong spirit of teamwork among colleagues.

EDUCATION

Long Island University, C. W. Post Campus, Brookville, NY

Master of Science in Medical Biology/ Biomedical Sciences May 2009. (GPA: 3.7/4.0)

K.L.E'S College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bangalore, India

Bachelor of Pharmacy May 2003. (GPA: 3.5/4.0)

CERTIFICATION/AWARDS

Registered Pharmacist, Karnataka State Pharmacy Council, Karnataka, India

PROFESSIONAL EXPERIENCE

Pharmalink Consulting Inc. Short Hills, NJ

Regulatory Affairs Associate February 2008 – Current

Pfizer Inc. Peapack, NJ

Change Management Coordinator February 2008 – Current

Emcure Pharmaceuticals USA, Inc. East Brunswick, NJ

QA/Regulatory Associate June 2008 – February 2010

Emcure Pharmaceuticals is emerging as a technology driven global player offering high quality and cost-effective healthcare and a fast growing Pharmaceutical Company with vision to manufacture innovative, high-tech products, which will satisfy the needs of customers.

• Managed, prepared and submitted regulatory applications focusing on CMC section for NDA and ANDA product filing.

• Acquired submission documents by interfacing with various departments and clients including R & D, QC, Production and Business Development.

• Represented Regulatory/Quality compliance at team meetings.

• Audited documents related to Production and Stability ensuring compliance. Responded to audit queries/ reports and conducted internal audits in Production and R & D Departments.

• Monitored and maintained records of the environmental controls, purified water system and stability chambers by interaction with outside vendors/ contractors as applicable.

• Managed and monitored preventive maintenance and calibration activities of Production equipment.

• Prepared, reviewed, updated and issued new documents like batch records, SOPs, protocols, labels, etc, neatly and accurately.

• Handled and maintained documents like change control documents, employee training documents, etc.

• Interacted with QA team of offshore parent company and with those of the contract manufacturers on quality issues.

• Documented and maintained accountability for stability study sample inventories on a daily basis, performed required inventory checks and generated sample pull schedules as required through WinProto software.

• Evaluated/trend stability data.

• Wrote investigation reports for any deviation observed in the stability procedure or stability chamber.

• Documented and maintained accountability for calibrations of all the machineries and equipments used in the production and testing of drug products through TrackPro software.

• Familiar with cGMP/GMP and ICH/21 CFR Part 11, 210, 211 Guidelines.

Certified Laboratories, Inc., Plainview, NY

Microbiology Lab. Tech June 2007 – December 2007

• Functions included all aspects of microbiological testing and identification, such as gram staining, morphology analysis and streaking for isolation

• Isolated and prepared cultures of microorganisms.

• Prepared and properly disposed off solutions and media.

• Performed tests on various products including, but not limited to dairy, juices, meat, refrigerated, seafood and spices to detect harmful microorganisms and to obtain information about sources of pollution and contamination.

• Assisted in the training of proper microbiology procedures and laboratory safety.

Sun Pharmaceutical Industries ltd., Piperia/ Dadra and Nagar Haveli, Silvassa, India

QA Officer II January 2006 - July 2006

• Provided assurance that clinical trials are conducted and data generated are reported in compliance with protocols, GCP/ICH and other regulatory requirements through document reviews and audits.

• Processed clinical trial complaints according to SOP.

• Ensured in-process controls and online checks are being performed appropriately.

• Participated into investigation of the market complaints and ensured corrective actions are taken.

• Reviewed and tracked the product related deviations and change controls.

• Ensured that RM, PM, in-process goods and FP are being tested as per approved/appropriate STP and standards and are released in compliance to respective specifications.

• Reviewed batch records and testing records.

• Ensured that stability sample testing is being done as per protocol/STP.

• Ensured that equipments & processes employed in manufacturing/testing are qualified and validated.

• Audited warehouse, RM and PM stores at other locations and compliance to CQA audit reports and observations.

Nebumed Pharma Pvt. Ltd., Cipla Ltd., Verna, Goa, India

QA Officer I March 2005 – December 2005

• Checked all export data and its upgradation.

• Updated calibration records and ensured timely calibration of all equipments/instruments used in production.

• Controlled cGMP at various stages of production.

• Collected stability and pre-shipment samples and retained as per SOP.

• Audited complete batch documents.

• Collected data and updated periodic observation records and retained sampling records.

• Dispatched final release of batch.

• Sampled validation batches and collected data at each stage during batch processing.

• Prepared, reviewed & updated SOPs, master production records and other documents related to manufacturing and packing.

Production Supervisor September 2004 - February 2005

• Responsible for production of several products like tablets and capsules, right from obtaining the raw materials through manufacturing and packaging.

• Supervised and supported a team of 28 workers and 10 machine operators.

• Ensured the efficient production with respect to capacity volumes, deadlines, costs and product specifications and directed daily activities to get products out of door in a timely manner.

• Coordinated with QC, QA, packaging material and raw material store, packaging and administration for the production of safe, pure and effective product.

• Trained and qualified new and existing workers and operators on cGMP, SOPs, procedures, guidelines, productivity, discipline, safety & company policies.

• Planned production, labor utilization, day-to-day work and documentation, coordinated, troubleshoot and procured activities as necessary.

• Knowledge of operating and handling of machines and apparatus related to production of tablets and capsules.

Production Officer II September 2003 - August 2004

• Worked in packaging & filling department and was responsible for production of F.F.S. respules & eye/ear drops.

• Maintained critically controlled areas and working system for quality production.

• Handled 12 workers and 3 machine operators.

• Knowledge of operating, maintaining and cleaning of packaging line and filling machines.

• Well acquainted with machineries, equipments and instruments used in packaging and filling department.

• Well acquainted with procedures of export packing.

Cosme Pharmaceuticals ltd., Bicholim, Goa, India

Production Officer I June 2003 - August 2003

• Responsible for manufacturing of sterile products for intravenous, intramuscular, subcutaneous and other parenteral route of administration and handled shop floor activities.

• Handled 4 workers and 2 machine operators.

• Undergone training in documentation, Validation, cGMP, etc

COMPUTER SKILLS

• Working knowledge of Microsoft office, Internet navigation, and e-mail.

• Familiar with both PC as well as Macintosh.

• Also familiar with Oracle Clinical software (used for CDM)

MISCELLANEOUS

• Pursued Master’s thesis under Dr. Maria Diverse, PhD and an Associate Professor in Pharmacology Department in Mount Sinai School of Medicine, NYC, on ‘Gi/o protein-mediated regulation of cardiac calcium channel complexes’

• Familiar with molecular biology techniques like ELISA, Western Blotting, and Immunoflorescence.

LANGUAGE SKILLS

Proficient in Hindi and Gujarati and familiar with Punjabi and Marathi.

INTERESTS

Physical fitness activities like Jogging, Swimming and playing Tennis, Gardening, Cooking and Traveling.

REFERENCES

Available upon request.

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