Qualification - B.Tech. / M.Tech. in Chemical Engineering only
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 CAPA’s 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 API’s & intermediate safety.
Identify and manage quality / safety related risks across all production lines.
Partner with the CRD team to seamlessly commercialize recent 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 succ
📌 Sr. Manager (India)
🏢 Unichem Laboratories
📍 India
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.