Vipul PatelPh.: (313) 580-6182 Email: vipul.69@hotmail.com

CAREER OBJECTIVE:

A challenging role in the areas of Laboratory operations, project management and continuous improvement that can utilize my skills and experience in achieving the business objectives successfully

SUMMARY:

An experienced Laboratory operations professional with over 20 years Pharmaceutical Quality control experience with respect to cGMP and over 12 years of laboratory management cGXP Compliance experience. Familiar with solid oral dosage (tablets/capsules) form non-aseptic operations. Extensive experience with successfully hosting Regulatory Agency inspections by the FDA for Quality Control Lab. Successful in establishing cGMP and cGLP Compliance programs, perform GAP assessment, Lab investigations and implement Immediate/long-term corrective actions for timely releases and continuous laboratory system improvement. Extensive experience in QC Laboratory restructuring, commissioning and decommissioning process. Integral part of journey in growth, expansion and project management under million to over 350 million dollars.

ACHIEVEMENT:

• Successful in representing Quality Control lab operations during FDA inspections since 2004. • Successfully restructured QC and AD to help streamline the Quality control functions for an efficient and

cost-effective operations resulting shorter product release times and ANDA submissions.• Played important role while working with Lachman Consultants on Sun Pharma’s corrective action cGMP

work plan: GAP analysis and remediation plan achieving compliance with FDA.• Successful in overseeing Analytical lab operation for Submission of over 30 ANDA applications and

writing FDA deficiency responses to achieve timely ANDA approvals. • Managed over Million dollar project purchasing laboratory instruments/equipments which includes

Installation, Qualification, maintenance and service contracts. • Increased the QC lab strength from 35 to 72 to meet the ANDA submission and QC release requirement.• Increased the QC productivity by 25% with efficient Instrument, Space and personal scheduling/

utilization.• Reduced the laboratory investigations by 20% with system improvement in training, root cause analysis,

CAPA, adequate Instrument maintenance and good documentation practices.• Successfully completed atypical investigation on APIs, and saved over 10 million dollars.• Performed complex Laboratory investigations in timely manner following necessary CAPAs. • Saved over $50,000/yr. by avoiding contract testing, minimizing Lab errors repeat analysis. • Saved over $100,000/yr. by performing In-House Standard qualifications and instrument calibrations.• Managed 24hr/7days Shift operations to meet the business needs in QC releases and ANDA support. • Managed healthy environment within the Laboratory operation by Promoting initiatives and positive

attitudes including hard work and dedications towards organizations, help retaining QC employees.

Associate Director, Laboratory Operations, April 2010 to Present Sun Pharmaceutical Industries, Inc. Detroit, MI.

Reporting to VP Quality, Sun Pharma Inc Direct Reports Quality Control Manager (Finished Product releases, Cleaning Validation)

Analytical Development Sr. Manager (Development, Validation, Transfer)Stability Manager and Stability Program CoordinatorRaw Material Manager (Raw material releases)

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Vipul Patel Ph: (313)580-6182

QC Compliance Manager (SOP, Investigation, Training system, Safety, Metrology)

EXPERIENCE

• Key regulatory compliance liaison to interface with regulatory agencies during audits of laboratory operations. Successfully handled US FDA inspections including several audits conducted by outside consultants and Customers.

• Direct and prioritize the activities for Quality Control and Analytical Development Department. Managed over 70 individuals in a QC laboratory with 5 direct report Managers.

• Review and approval of Laboratory documents but not limited to STPs, SOPs, Change control documents, Planned events/Deviations, CAPAs, APRs, ANDA submissions, deficiency responses, process validation & cleaning validation, DI water system and environmental monitoring program.

• Adherence of cGMPs, GLPs, Compendial Guidances FDA, ICH, USP, DEA and 21 CFR Part 11• Laboratory Software Data integrity management including : Waters Empower 2, Track wise, LIMS, ERP• Establishment of Raw material, in process, finished product and stability specifications as well as

expiration dating on commercial products to assure regulatory compliance.• Focused on timely release of Raw materials, In Process, Finished Products, and Stability testing with

timely investigations initiations, write ups and closures.• Work with AD to coordinate method validation and transfers from AD to QC and other sites.• Management of Analytical Instrument/equipment calibration and Qualification programs.• Review of analytical data for compliance to specifications; leading OOS,OOC and OOT investigations• Management of Laboratory Incident Investigation/deviation program with effective root cause analysis and

adequate Corrective and Preventative actions followed by timely closure and effectiveness checks.• Hands on with trouble shooting experience in HPLC, Dissolution and UV-VIS. • Continuous improvements on documentation practices and training Program in Quality control lab.• Overseeing the Stability program includes review of Stability Protocols/reports and Summaries.• Evaluate and qualify alternate sources of API and prepare for PAS filings with Regulatory affairs.• Responsible for the development of short and long term goals of QC Laboratory.• Coordinate (Analytical) Technology transfer with various API sources and Contract Development sites.• Capital expenditure and budget preparation for Laboratory operations.• Interaction with contract laboratories, customers, auditors and instrument vendors.• Coordination with Regulatory Affairs Department for ANDA submission to the Agency.• Aligns resources with business unit needs to ensure on time execution and release of testing results• Ensure timely Field Alert Reporting requirements are met including CBEs and PAS.• Coordination of site transfer Projects between the multiple sites among Sun Pharmaceutical companies.• Participation on CTL certification and review of Complaint Handling investigations (Quality and ADE).

Senior Manager, Laboratory Operations, Oct 2006 Sun Pharmaceutical Industries, Inc. Detroit, MI.

Quality Control Manager - 2004 Sun Pharmaceutical Industries, Inc. Detroit, MI.

Quality Control Asst. Manager/Supervisor - 2002, Group Leader - 1999. Sun Pharmaceutical Industries, Inc. Detroit, MI.

• Direct and coordinate the activities in the Quality control lab which includes Raw material, finished product, stability, Method Validation/Transfer, process and Cleaning Validation testing.

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VipulKumar V. Patel Ph: (313)580-6182

• Review and approval of Standard test procedures including SOPs, Change control documents, Laboratory investigations, deficiency responses. Ensure training qualifications for all QC staff for cGMP’s, safety.

• Performance of QC OOS/OOC and OOT investigations along with CAPA closure and trend analysis.• Laboratory Instrument IQ, OQ and PQ and SVC contract with software management.

ANDA Stability Analyst, Jan 1998 - Jan 1999Gen Pharm Inc. Toronto, Ontario, Canada.

• Stability and Quality control analysis, reference standard qualification and performing Lab investigations.

Research Assistant, Oct 1995 - July 1997Sun Pharmaceutical Industries Ltd. Baroda, Gujarat, INDIA

• Analytical Method validation, Documentation preparation, Submission, Stability testing, Stability trend/summaries, organic synthesis analytical support and reference Standard management.

Laboratory Chemist, Oct 1993 – Sept 1995GSFC Ltd (Caprolactum Project), Baroda, Gujarat, INDIA

• Quality control/ Plant control QC raw material, in process and release testing, Instrument calibrations.

Chemist, March 1993- Sept 1993Indu Nissan Oxo Chemical industries Ltd, Baroda, Gujarat, INDIA

• Quality control/ Plant control QC raw material, in process and release testing.

TRAINING: Corporate and Individual Responsibility and Liability for GMP Compliance. GMP for Quality Control and Analytical Development Laboratories Quality System Manual Training Quality System Approach to Pharmaceutical cGMP Regulations Training. Investigation and Root Cause Analysis Training. Effective Communication / Healthy Confrontation. Motivation & Recognition.

CONFERENCES:

1) FDA Conference on Handling and Investigating Out-of-Specifications and Out-of-Trend Results.2) The USP/GPA Conference on Residual Solvent Requirements on Excipients and Drug Products.3) The FDA Conference on Bulletproof Investigations and CAPA’s.

EDUCATION: MS Organic Chemistry, 1992 South Gujarat University, Gujarat, INDIA

BS Chemistry, 1990Sardar Patel University, Gujarat, INDIA

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Vipul Patel Ph: (313)580-6182

HOBBY: Travelling, Cricket, Painting

LANGUAGES: Gujarati, Hindi

Current Status: Permanent Resident of USA

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