Director - Quality Assurance - Manufacturing Practice

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.

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.

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.

Compliance and Audits:

- Collaborate across disciplines (e. , 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.

- Respond promptly to observations from audits, implementing corrective and preventive actions.

Policy Implementation and Continuous Improvement:

- Enforce Abbott policies and procedures at the site.

- Drive continuous improvement in quality systems and processes.

- 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.

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.

- 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.

- Review and Improvement: Conduct review meetings with senior management to identify opportunities for improvement in products, processes, and systems.