Md Sakil Amin

Master's

Pharmaceutical Sciences

General Pharmaceuticals

Head of Quality

- Position Summary: This position provides technical leadership to the Quality Operations team for manufacturing and testing of Biotech and Pharmaceutical Products like ablet, Capsules, Syrup, SVP, LVP, Eye Drops, Prefilled Syring, Eye Ointment and Lyophilized - Injection. Work as a site quality lead for development and implementation of Pharmaceutical Quality System (PQS). Responsible to supervise activities related to QA, QC, Microbiology & Regulatory Affairs, and handle critical failure. Manage regulatory audits like - USFDA, UKMHRA, EU GMP, WHO etc. Report to the managing director in case of quality related issues and execute management - Job Responsibilities - Ensure preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities like - USFDA, MHRA, WHO and EU - Provide guidance on process validation and method validation of Terbinafine Tablets 250 mg and Itraconazole 100 mg Capsules for dossier submission to EU market - Provide guidance on process development and method development of Biotech products like Erythropoietin Alfa, Darbepoetin - Filgrastim and Preg Filgrastim - Direct, Coordinate, Plan and monitor all activities for smooth operation of Quality Operations (QA, QC, Microbiology and International Regulatory Affairs) Division to support commercial supply as per cGMP and GLP regulation. And also maintains site & product quality standards as per GMP guidelines with robust quality system - Develop and oversee a phase appropriate QMS including the writing and reviewing of standard operating procedures (SOPs - Provide guidance on the management of Deviations, CAPAs, OOS/OOT investigations, Risk Management and change controls - Review and approve Cleaning Validation Protocol and report, and provide instruction to design cleaning procedure. Provide guidance to calculate PDE and set MACO limit during protocol preparation - Review and approve qualification protocols of facility, utilities and equipment's like IQ, OQ & PQ protocols of HVAC, WFI, Purified - Review and approve Computer system validation protocols like Functional Risk Assessment (FRA), GxP Assessment, System - Classification, System Requirement Specification (SRS), and IQ, OQ & PQ protocol. Approve CSV risk assessment report with mitigation plan, after validation - Approve stability study protocol, procedure and report according to ICH guideline and ensure stability study according to stability - Review and approve Quality Risk Management (QRM), performed using FMEA, FTA & HACCP methods and approve risk reduction - Review and approve protocol and report for gowning qualification & environmental monitoring and provide training on aseptic - Lead Quality Management activities such as development of Quality Manual, Quality Management Plan, Quality Agreement with third party vendors, vendor management and qualification - Ensuring that there is a self-inspection program in place which is communicated to operations to meet the requirements - Establish procedures that define the method validation and verification activities, and method transfer between department/sites - Direct the Incoming QA (IQA), Manufacturing QA (MQA), Aseptic Core Monitoring (ACM), Sterility Assurance, and Client QA - Ensure effective batch record review processes support batch disposition decisions within established timelines (TATs) and incorporate continuous improvement feedback to reduce the overall number of errors, deviations, and comments - Works with the company's external suppliers including Clinical Research Organizations (CROs) and contract labs to ensure consistent - Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global - GXP/PV/CSV regulations and guidance - Ensures that quality activities in support of corporate initiatives are adequately staffed and that timelines are met in a quality manner - Establishes and manages quality metrics, including Right First Time (RFT), responsible for ensuring that all policies and procedures - Serve as the Management Representative, leading management review meetings, and ensuring that quality remains at the forefront of our operations - Ensure EHS (Environment, Health and Safety) within compliance of factory premises and people - Manage and track team progress against both short-term and long-term goals. Prepare developmental reports for individual team - Prepare Balance Score Card of the quality operations division considering Five years strategic plan, one year execution plan, identify - KRA & KPI for department and individual employee, propose initiative to achieve the plan and verify strategic target vs achievements of the division - Develop and track the annual budget for the division. Prepare CapEx (Capital Expenditure) and OpEx (Operating Expense) for the division and prepare Annual Operating Plan (AOP - PROFESSIONAL EXPERIENCE