Job Overview
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Date PostedJanuary 2, 2022
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Location (State / UT)
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Expiration dateMay 9, 2024
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Experience18 Years, 25 Years +
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Job Summary
Manage daily production targets & comply with cGMP guidelines in the PMA area.
Areas Of Responsibility:
- Authorized to sign as an approver & also authorized to sign as a checker/verifier in
- Master Batch manufacturing record, Area cleaning & sanitization logbook/formats, etc.
- Risk assessment, process validation protocol, Incident, and Investigation report, action compliance, and closure.
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- CAPA plans and closure, Protocols & reports, URS, MF/MPS.
- Internal Quality Audit Compliance and closure.
- Change control, Standard Operating Procedure (SOP)
- Any other documents used for the execution of activities.
- Overall responsible for the production activity related to the production department.
- Responsible for establishing new procedures, and maintaining and updating existing procedures in the production department.
- Responsible for co-maintain, along with the Quality Assurance manager, GMP in the production department.
- Responsible for establishing a system in accordance with Good Manufacturing Practice guidelines.
- Responsible for Good Manufacturing Practice training to staff in the Sterile and non-sterile departments.
- To coordinate with FDD to Exhibit batches of new Products.
- Coordinate with the Quality control department in matters relating to product quality.
- Responsible for production planning schedule, control, and execution.
- Responsible for optimization of the resources namely men, material, and machines in budgetary norms.
- To make daily/monthly reports to the management on achieving the activity concerning the management.
- Coordinate with the Engineering department for preventive maintenance schedule.
- To coordinate with the Warehouse for the materials to achieve the schedule plan.
- To undergo functional training, cGMP training or any other training identified as per schedule.
- Any other responsibility assigned by the department head after ensuring the relevant training status.
Educational Qualification: B Pharm/M Pharm
Experience: 18 to 25 yrs. in Parenteral production.
Location: Halol (Gujarat)