Quality Control Manager
Resume:
Faheem Khan
Murrieta, CA ***** ********@*****.***
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Quality Control Consultant
Energetic, resourceful, detail orientated Quality Control Manager with 10 plus years of Quality Control experience in the pharmaceutical and medical device industry. Strategic in thinking, and outstanding in execution. Extensive experience and knowledge of Equipment Validation, FDA, EU, HBFBI regulations and ICH, ISO guidelines and ASTM E2500, Annex 11. Strong interpersonal skills including supervising, coaching, mentoring and interfacing with government and customer in compliance audits.
Key Attributes Include:
• Hands on management style • Result driven • Project Management
• Effective interpersonal skills • Strategy thinking • Flexible
• Organized/Detailed process • Innovative • Safety Orientated
PROFESSIONAL EXPERIENCE
Abbott Vascular, Temecula, Ca 2006 – 2012
Worldwide manufacture of Pharmaceutical and medical devices.
Group Leader - Analytical Operations (2009 – 2012)
Managed a staff of 8 chemists and technicians in monitoring compliance and quality aspects of Analytical laboratories.
• Led a project team in implementing the project of new customized calculations in SQLLIMS. Achieved $600K annual saving.
• Consistently achieved highest cGMP and regulatory compliance scores.
• Developed and executed the project plan for Analytical Chemistry to update 500 equipments documentation to GAMP5 requirements. Audit readiness.
• Developed Validation Master Plan for equipment and utilities.
• Managed CAPA workflow, including assess, review and approved records, ensured timely completion and effectiveness of actions
• Conducted investigations (OOS, OOT) related to the product quality and non-Compliance issues, and timely closure of exception reports, 25% efficiency.
• Planned and managed projects for validation and implementation of 21 CFR Part 11 compliant laboratory software, including Waters Empower HPLC systems, Agilent Chemstation Chemstore.
• Plan and coordinate Quality Control support for the manufacture of solid dosage including testing, reports, audits and vendor qualification.
• Responsible for conducting the trainings to Quality Control laboratory staff on analytical instruments, e.g HPLC,GC, TGA, ICP, GCMS, Dissolution tester, FTIR, etc.
• Conducted vendor’s audits for compliance and quality control.
Senior Chemist - Analytical Operations (2006 – 2009)
Managed the activities of the Analytical Operations Laboratory
• Authored and implemented validation master plan for 27 Stability environmental chambers. The project completed prior to schedule deadlines resulting in savings of $100K.
• Managed the evaluation, selection, contracting, scheduling, and training of full time employees and contractors.
• Developed and implemented Risk based approached for automated equipment validation
Torpharm Inc.Etobicoke, Canada(Apotex group of Companies) 1997-2006
Manager Laboratory Technical Services 2001 - 2006
Managed 18 chemists and technical staff
• Implemented Laboratory Life Cycle processes by leading LIMS phase expansion projects. Successfully rolled out to regional and international sites.
• Providing assistance with technology transfers, Ruggedness and Robustness.
• Prepared and maintained all SOP’s, IQ/OQ documents for Quality Control Laboratory.
Quality Control Supervisor 1999 – 2001
• Supervised Quality control lab staff to ensure operational efficiency, regulatory compliance and personnel development of the staff.
• Developing and maintaining SOP’s, test methods and provide training, as required.
Quality Control Analyst III 1998 – 1999
• Performed analysis of raw material, in-process and finished products, using analytical instruments and established analytical procedures and techniques within set deadlines.
• Troubleshooting of all instrumental and difficulties encountered by analysts and senior analysts.
Quality Control Analyst II 1997 - 1998
• Conduct testing of Raw materials and finished products by using GC, HPLC, FTIR, UV and dissolution tester and other analytical techniques.
Professional Experience Prior to 1997
Abbott Laboratories Ltd, Karachi, Pakistan 1994 - 1996
Group Leader Raw Materials
Merck Frosst Ltd Karachi, Pakistan 1990 - 1994
Chemist
EDUCATION/CERTIFICATIONS
• Master of Science in Chemistry Qauid-e-Azam University of Islamabad, Pakistan.
• Bachelor of Science Chemistry University of Karachi, Pakistan
• Project Management Certificate: Kaplan University, Davenport, Iowa
• CAPA Certification
• Labware LIMS System Administrator certification
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