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 current products.
- Collaborate with projects & QA team for new 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 mandatory.
- Exposure in managing and working with regulatory authorities and norms.
- In-depth experience and knowledge of API manufacturing processes, chemical unit operations and scale up.
- Should have strong leadership skills.
- Good communication and interpersonal skills.
- Proficient in MS Office – i.e. Excel, Word, and PowerPoint.
- Ability to work in a fast-paced, demanding, and time-line-driven environment.

📌 Sr. Manager / AGM Production (Site Production Head) (Pithampur)
🏢 Unichem Laboratories
📍 Pithampur