Kashif Shakil
Senior Quality Manager @SUN PHARMA
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WORK HISTORY
Senior Quality Manager @SUN PHARMA
Brampton, ON, CA
Works closely with Business Development, Commercial Operations and Product Launch teams to provide Quality Assurance oversight of all product supplies to third party customers, importers and distributors. Review and approve manufacturing sites master production documents, Quality Deviation & Product Quality Complain investigations, Process, Analytical and equipment validation protocols and reports and Change Controls. Update SAP QM master data for new products. Manage site training, SOP, EBR and confirmatory testing programs Build working relationships with the respective Quality functions of third party customers and manufacturing site Quality Operation worldwide to continuously improve QM processes and product quality. Liaise between Sun manufacturing sites and customer to support quality related activities relating to customer operations and products. Handling customer related quality incidents in accordance with both Sun and customer quality standards and expectations.
EDUCATION
Karachi University
M.Sc., Analytical Chemistry
SKILLS
ABOUT KASHIF SHAKIL
Energetic quality assurance / quality control professional experienced in managing quality assurance / quality control program. Extensive cross-functional expertise in manufacturing and distribution and cross-category expertise in Pharmaceuticals, Beauty care and Healthcare. Creative and effective strategic planner and problem solver. Excellent projects management skills. Proficient in SAP QM, Excel, SPC applications and Electronic Batch Record.Specialties: Project Management, Quality Management System,Laboratory Management, SAP QM, Supplier Development & Organization capability building, Quality Strategy-Successfully completed Electronic Batch Record Manufacturing Execution System project-Successfully achieved compliance rating in Health Canada, FDA and Customer cGMP audits-Led startup and qualification of QA Laboratory for a brand-new Apollo HBC manufacturing site -Successfully developed and deployed QA/QC system for startup of P&G F & HC manufacturing site -Successfully led and completed implementation of SAP (Quality Management)-Achieved 100% Quality Assurance Capability for P&G multiple category site -Successfully managed and achieved compliance rating for contract manufacturing sites in cGMP audits-Successfully managed and achieved compliance rating at P&G distribution center and 3PL-Deployed starting material quality system, achieved reduction in material released time and inventory-Have sound knowledge of ISO Standards, HC & FDA Regulation, ICH Guidelines, SQF Quality program
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