RESPONSIBILITIES
- Strategic production planning and coordination with senior management.
- Direct production activities to meet budgeted norms and delivery timelines. Ensure production of intermediates and API'S according to pre-approved instructions.
- Ensure effective utilization of resources (Man, Machine & Material).
- Drive continuous improvement initiatives to enhance yield and quality of products.
- Oversee inter location transfer of API & Intermediates.
- Lead and successfully complete customer and regulatory audits.
- Prepare, review and approve standard batch production instructions according to written procedures.
- Lead QMS, OOS and OOT investigations, ensuring timely closure of CAPAs and market complaints.
- Review and approve validation protocol, change control proformas and planned deviations.
- Coordinate with RA, CQA, PR and PRA for routine development and process implementation of APIs in plant.
- Coordinate with other departments on documentation and actively resolve plant technical issues.
- Coordinate to upgrade the facility as per GMP and safety systems.
- Lead HAZOP, HIRA and Process Hazard Analysis to mitigate manufacturing risks.
- Responsible for all APIs & intermediate safety.
- Identify and manage quality / safety related risks across all production lines.
- Partner with the CRD team to seamlessly commercialize new products.
- Collaborate with projects & QA team for recent plan implementation.
- Evaluate proposed changes in product, process and equipment.
- Develop subordinates to take on higher technical and managerial responsibilities.
- Ensure timely and documented compliance training for the entire production team.
- Participate in the Management review meetings.
DESIRED SKILLS
- Experience in Technology Transfer and / or Technical Services will be an added advantage
- Extensive experience in production department in a reputed API pharmaceutical company (Regulatory).
- Proven track record of successfully managing USFDA audit is a manda