Head of Audit and Compliance ( QA)
Dow University of Health Sciences
Total years of experience :32 years, 10 Months
Managed and supervised the Microbiology laboratory activities of Aseptic and Non sterile area.
Conducted and executed Aseptic Manufacturing review by forming a cross functional team including Engineering and Production departments.
Ensured and Supervised all validation of equipment including Laboratory and Production area Sterilisers and Ensured requalificatiin
Prepared Endotoxin control policy to ensure control of endotoxins in Aseptic Manufacturing processes
Prepared and approved simulation trial protocols for aseptic filling and monitored execution of the activity as per the predefined schedule.
Ensured and maintained compliance of QMS, Risk management, RCAs and CAPAs and Change Controls.
Conducted Gembas at departmental level as well as cross functional departments
Conducted Internal audits, Self Inspections and External Audits ( Supplers and Service providers)
Planned and Budgeted resources, OPEX and CAPEX for the department.
Conducted trending and evaluation of Environmental and Utilities monitoring results for improvements and to control proactively any potential adverse results
Ensured and Monitored validations and re qualifications of Test methods and equipment
Ensured Environmental health and safety policies are followed and implemented
Ensured timely testing and releases of products
Lead a team of 7 microbiologists and 2 lab attendants
Monitoring and Quality Control of Microbiology Lab activities relating to Sterile and Non-Sterile areas.
Ensured all activities are aligned with the company's policies and SOPs.
Conducted Internal Audits and implemented Safety requirements, executed Facility and Process validations including Clean rooms and water systems.
Conducted Equipment and Tesr Method validations.
Prepared and approved SOPs and investigation report writing, trend analysis and assessment of Environmental monitoring and water results based on retrospective data.
Management and supervision of Microbiological Analysis of all input materials, products, utilities and finished products.
Management and supervision of facilities and process validations including Microbiological tests and assays within the ambit of Validation Master Plan and SOPs
Microbiological Analysis of Products, Raw Materials and Utilities ( Water System, Product Contact Gasses etc)
Environmental Monitoring, Sterility testing, Microbiological assays of Antibiotics and Vitamins, Bacterial Endotoxin testing.
Microbiological Assays of Antibiotics and Vitamins, Sterility testing, Bacterial Endotoxin testing, Testing of Water for Injection
Environmental Monitoring of Sterile area, Microbial limit test of products and raw materials, Distilled water, Deionized water and Water for Injection.
Pyrogen testing on Rabbits
Seasoned Pharmaceutical Microbiologist and QA expert. Established the Quality Assurance department in my current organisation resulting in successful approval of Drug Manufacturing Licence and GMP certification. Certified Quality Auditor acquired certification from GSK Singapore.
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