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Job Description: Quality Assurance (Leadership) About the Role This role involves strategizing and planning for Quality Assurance and Quality Control to ensure smooth operations across various blocks. You will lead continual improvement efforts for GMP aspects, manage departmental budgets, and oversee performance against agreed targets. Additionally, you will ensure compliance with regulatory standards, implement policies, and drive quality system enhancements at the site. You will also be responsible for the below: 1. Strategize and Plan: Develop strategies for Quality Assurance and Quality Control to ensure smooth operations across ODF, LVP, and Hormone blocks. Drive continual improvement in GMP aspects within the facility, systems, and procedures. 2. Budget and Performance Management: Manage budgets for capital and operating expenses, ensuring departmental activities align with financial targets and timelines. Set and monitor goals for QA and QC, guiding teams to achieve KRAs. Lead and assess performance, providing necessary support and communication. 3. Compliance and Audits: Collaborate across disciplines (e.g., Manufacturing, Warehouse, Engineering) to maintain readiness for inspections by regulatory agencies, both internal and external. Conduct audits as scheduled, regularly evaluating the effectiveness of the Pharmaceutical Quality System. Ensure timely submission and compliance of regulatory documents and filings. o Respond promptly to observations from audits, implementing corrective and preventive actions. 4. Policy Implementation and Continuous Improvement: Enforce Abbott policies and procedures at the site. Drive continuous improvement in quality systems and processes. o Implement cyber security measures at the site. Maintain a GXP-compliant document control system. Ensure batch releases comply with policies, procedures, and regulations. Update documents according to new pharmacopoeias and regulatory guidelines. 5. Approval and Risk Management: Approve or reject materials based on validated methods, pharmacopeia methods, or in-house methods. Coordinate product recalls according to site procedures and liaise with Regional Quality for recall authorization. Manage quality risks based on scientific knowledge and process experience, ensuring patient protection. Approve site documentation as applicable. Handle exceptions, deviations, and change control activities. 6. Training and Best Practices: o Ensure training and effective implementation of current Good Manufacturing Practices (GMP). Uphold Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) at the site. 7. Review and Improvement: o Conduct review meetings with senior management to identify opportunities for improvement in products, processes, and systems.