Murtaza Kapasi

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Director of Quality Assurance

Cosmaceutical Research Lab Inc.

Jun 2023 - Current (3 years 3 months)

• Oversee all Quality Assurance (QA) and Regulatory Affairs compliance activities across the organization, ensuring adherence to established standards and procedures. • Perform comprehensive oversight related to manufacturing/ packaging complaints, deviations, change controls and analytical investigations to ensure compliance with cGMPs, GLPs and SOPs. • Ensure compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) regulations during regulatory audits. • Act as the primary point of contact for regulatory agencies such as Health Canada and the US Food and Drug Administration (USFDA), responsible for addressing inquiries and providing necessary documentation. • Accountable for t

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Sr. Executive Quality Assurance

Sun Pharmaceuticals Industries Limited

Oct 2016 - Apr 2023 (6 years 7 months)

• Acted as Internal Audit Coordinator, collaborating with the Internal Audit Team to plan and execute internal audits, ensuring xGMP compliance across cross-functional departments. • Organized and coordinated Corporate Quality Audits, preparing audit responses to address findings and ensure compliance with all observations. • Initiated and tracked Corrective and Preventive Actions (CAPA) in response to audit findings, working with cross-functional teams to drive timely resolution. • Managed the preparation of Annual Product Quality Review (APQR) for all products. • Conducted quarterly reviews of Out of Specification (OOS), Out of Trend (OOT), and Laboratory Incident trends to ensure regulatory compliance and process improvements. • Reviewed

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Executive Quality Assurance

Cadila Healthcare Limited (Zydus Cadila)

Mar 2016 - Oct 2016 (8 months)

• Monitor and ensure timely testing of finished products within Quality Control, aligning with deadlines and ensuring closure of QMS actions to meet targets. • Conduct lab rounds and provide training to analysts and reviewers, improving testing and reviewing competencies. • Investigate Out of Specification (OOS) and Out of Trend (OOT) results for raw materials, packaging, intermediates, finished products, and stability samples. • Ensure timely release of finished products using LIMS and SAP applications. • Verify analytical and Batch Manufacturing Records (BMR) for accurate reporting and proper documentation. • Review and approve lab incidents, conducting investigations using basic investigative tools. • Review calibration reports for all Q

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Executive Quality Control

ZCL Chemicals Limited

Jan 2015 - Mar 2016 (1 year 3 months)

• Oversaw and planned daily quality control analyses, delivering accurate and timely results to support manufacturing processes. • Ensured proper maintenance and calibration of laboratory equipment to achieve precise and reliable results. • Monitored stability samples and maintained proper storage conditions for consistent product quality. • Developed stability protocols to evaluate the long-term stability of active pharmaceutical ingredients (APIs). • Coordinated routine stability analysis, ensuring products met established quality specifications. • Reviewed and verified analytical records for in-process samples, intermediates, stability samples, raw materials, packaging materials, and finished products to ensure compliance with regulatory

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Officer Quality Control

Glenmark Generics Limited

Jan 2014 - Jan 2015 (1 year 1 month)

• Perform various laboratory tests, including physical and chemical analyses, to evaluate the quality and stability of drug products. • Record and document laboratory results promptly and accurately. • Responsible for the calibration of analytical balances, pH meters, and other lab instruments. • Receive and manage samples from the manufacturing plant, coordinating analysis and testing schedules.

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Officer Quality Control

Exemed Pharmaceuticals

Aug 2012 - Jan 2014 (1 year 6 months)

• Receive samples from the manufacturing plant and develop a detailed analysis plan. • Perform accurate analysis of raw materials, intermediates, and finished products to ensure compliance with specifications. • Maintain a clean and safe laboratory environment by following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). • Conduct qualifications for working standards and maintain comprehensive records, including Certificates of Analysis (COA).

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Officer Quality Control

Cadila Pharmaceuticals

Aug 2011 - Jul 2012 (1 year)

• Receive samples from the manufacturing plant and plan analysis accordingly. • Perform chromatographic (HPLC) analysis of raw materials, intermediates, and finished products, ensuring they meet required specifications. • Maintain a clean and safe laboratory environment by adhering to GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) guidelines.

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Executive Quality Control

RPG Life Sciences Limited

Jul 2009 - Aug 2011 (2 years 2 months)

• Receive samples from the manufacturing plant and plan analysis accordingly. • Perform chromatographic (HPLC) analysis of raw materials, intermediates, and finished products, ensuring they meet required specifications. • Maintain a clean and safe laboratory environment by adhering to GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) guideline.

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