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Production Leadership Position
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Operations Manager
About the Role:The Operations Manager plays a vital role in overseeing the overall operations and activities of the drug product plant. This includes managing production and manpower planning, ensuring products are manufactured and stored according to approved procedures and documentation, and maintaining quality standards.
Key Responsibilities:- Manage production and manpower planning for the drug product plant.
- Ensure products are manufactured and stored as per approved procedures and documentation to maintain quality standards.
- Review and ensure execution of batch production records (BFR, BPR, etc.) as per cGMP requirements.
- Qualify equipment and instruments as per schedule.
- Conduct product validations in line with regulatory requirements.
- Monitor and maintain minimum stock of consumables, logbooks, and status labels.
- Perform preventive maintenance of equipment as per the defined schedule.
- Coordinate with service departments (QA, QC, Stores, SCM, EHS, E&M) for production-related activities.
- Attend GMP and safety trainings and implement training outcomes at the workplace.
- Demonstrated experience in independently handling regulatory audits.
- Hands-on experience in process investigations, deviations, and handling customer complaints.
- Possess knowledge and hands-on experience in serialization.
- Possess knowledge and hands-on experience in equipment qualification.
- Knowledge and practical experience in Lean and Six Sigma methodologies.
- Opportunity to work in a dynamic environment.
- Chance to develop skills in operations management.
- Competitive salary and benefits package.
