Erfan Syed  Asif Author of Evaluating Organization Development
FEATURED AUTHOR

Erfan Syed Asif

Quality Unit Head
Pharmaceutical Solutions Industries

I am quality professional, with consistent and progressive experience of over 18 years in the pharmaceutical industry and research institutes in Canada, USA, Germany, Pakistan and UAE. I hold a Ph.D. degree in Organic Chemistry and my experience comprises of a wide range of Pharmaceuticals operations in terms of Quality Assurance, Quality Control, Validation and GMP consultancy.

Biography

Gulf Pharmaceutical Industries, UAE
Manager Quality Assurance June 2011- May 2012
- Responsible for the commissioning, qualifications and validation of new Plants for the manufacturing of liquid and semi-solid products.
- Generating Master Validation plan for the new facility.
- Initiated change controls and protocols for qualification of various equipment, manufacturing processes and cleaning procedures.
- Responsible for hiring new staff for the new plant.

Manager Quality Control Dec. 2005 – May 2011
- Responsible for the administrative routine in the quality control laboratory.
- Review of raw material, packaging, Bulk and finished product’s specifications.
- Responsible for analyses of raw material, packaging commodities, Bulk products, process and cleaning validation samples.
- Providing support to Quality Affairs Director in investigating and responding market complaints.
- Coordination with the production, Packaging managers and Product Development Laboratory director in matters concerning production and introduction of new products.
- Conducting in house annual re-qualification of analytical instruments (GC & HPLC units).
- Coordinating with Regulatory Affairs to fulfill Health regulatory requirements as and when required.
- Developed Master Vendor approval Plan and responsible for conducting GMP audits of new vendors for GMP compliance as per the Master Plan.
- Conducted API manufacturers GMP audit as per Master Vendor Qualification Plan.
- Generated Cleaning Validation Master Plan and supervised the cleaning validation program.
- Generating and updating SOPs as per FDA recommendations.

CIBA Vision Sterile Manufacturing Canada (Novartis)
Manager Validation Dec. 2003 – Nov. 2005
- Lead a department of 10 personnel responsible for equipment qualification, calibration and process / cleaning validation of large and small volume parenterals.
- Leading various projects for the GMP upgrade of the facility, development of new SOPs, negotiating with outside consultants and leading them for projects.
- Lead the upgrade project for new packaging area, HVAC, blow mould machines, sterile filling machines and lines, new hot and cold-water loop system and manufacturing pressure vessels of different sizes.
- Validated 06 new LVP products as well as retrospective validation of 21 products to meet the commitment with Novartis and FDA.
- Responsible for quarterly re-qualification of Ethylene oxide and gamma radiation sterilization cycles.
- Responsible for half-yearly process simulation media fills for all six filling machines in the area.
- Generated and validated new Ethylene oxide sterilization cycle with outside laboratory STERIS INC.
- Generation of Master Validation plans for process, cleaning procedures, equipment qualification and Process Simulation.
- Responsible for reviewing and approval of SOPs, Master Manufacturing Formulae and Change Control request forms generated from different areas of operations.

TORPHARM INC. (Apotex group of companies) Canada Validation supervisor Sep. 2001 – Dec. 2003
- Lead a group of 9 people in various activities related to process and cleaning validation.
- Reviewing and approving validation protocols and final reports.
- Validated and re-validated an over all 28 new products in solid dosage form.
- Generating and reviewing Change Control forms generated to support the business.
- Reviewing regulatory dossiers to ensure compliance for validation part before ANDA submission to FDA.
- Setting goals and objectives and carrying out performance review of the subordinates.
- Providing support to manufacturing, supply chain, Regulatory Affairs, New products committee, compliance and other client groups.
- Provide support in establishing supply chain system by generating various SOPs to coordinate with the program.

PICARD TECHNOLOGIES INC. Canada
Validation / Project Specialist Dec. 1999 – Aug. 2001
- Worked on projects at Pharmacia Upjohn, Michigan (USA) for validation (IQ/OQ/PQ) for various sterile area equipment, processes and systems.
- Project with Glaxo Smith Kline, Mississauga, Canada for Y2K upgrade and re-qualification of Korsch tablet presses.
- Generated SOPs and provided support for other regulatory compliances to Air Liquide Canada (Medical gas manufacturers) based on FDA regulations.
- Provided GMP and GLP related and validation trainings to the specialists working on various projects in Canada and USA.

MERCK SHARP & DOHME Pakistan (affiliate of Merck International USA)
Quality Operations Manager Sep. 1997 – Jul.1999
- Responsible for daily planning, products testing and releasing by QC.
- Providing support to Director Quality operations for annual budgeting.
- Carried out the Laboratory assessment process and implemented the system for all basic GLP elements.
- Handling of market complaints and dealing with Health Inspectors and auditors.
- Conducting on-going stability for all finished products.
- Validation of analytical and stability indicating methods.
- Providing support in validation of facility, equipment and products to maintenance department.
- Assessment of Laboratory processes and implementation of GMP / GLP as per ISO 9000, Merck Manufacturing Standards, FDA and local drug rules.

ABBOTT LABORATORIES Pakistan Apr.1997 – Aug.1997
Manager Technical Affairs
- Performing development of products and validation of manufacturing process.
- Solving products problems by investigating and re-validating the processes.
- Support in the development of new products and coordinating with International Development Centre of Abbott Laboratories in UK.
- Developed the multivitamin product with three granulation including one granulation for Zinc and Vitamin K.
- Submission of registration files to local Ministry of health.
                  
Assistant Manager Validation Apr. 1995 – Mar. 1997
- Validation of analytical methods, manufacturing equipment, processes and systems.
- Investigation and implementing corrective actions for perpetual product problems.
- Validated an over all of 24 new products including antibiotic and multivitamin tablet products, capsules, suspension, ointments, gels, injectables and the first direct compression multivitamin product in Abbott Laboratories.
- Validated various new equipment and utilities including cone blender, tablet press and the new wastewater treatment plant and water loop system.
- Conducting investigation and writing reports to respond market complaints.
- Generating and making presentations of trend reports for various QA functions to all Directors and Managing Director of the company on monthly basis.


Senior Chemist (Group leader) Mar. 1994 – Mar. 1995
- Responsible for planning and assigning work to analysts in raw material and bulk products sections.
- Supporting Manager QC for annual budgeting and calculating head counts.
- Generating and implementing SOPs wherever required.

Education

    Relationship based Quality operations, Target oriented , Identifying and generating site quality procedures, Validation and qualification, GMP and GLP training, Implementation of Corporate policies and procedures, Investigations and problems solving , Report writing, Computer Literacy, Well-developed interpersonal, communication, organizational, presentation, leadership, innovative, creative thinking and negotiation skills.  Easily able to interact with people from diversified backgrounds.

Areas of Research / Professional Expertise

    “Phytochemical Investigations of the Constituents of BUXUS Species” and,
    “Syntheses with Organo-metal Complexes”

Personal Interests

    Cricket, music, books reading

Books

Featured Title
 Featured Title - Quality Operations Procedures for Pharmaceutical, API - 1st Edition book cover

News

New Responsibilties

By: Erfan Syed Asif

My new position is Head the of Quality Unit. I started my new role on November 03, 2012. I will be responsible for the Quality Control, Quality Assurance and Validation departments.