Job Description:
- Responsible for reviewing, approving and distributing work instruction for manufacturing activities.
- Carry out production activities as per production plan.
- Responsible to decide new batch production.
- Responsible for monitoring batch process. Review online documentation related to production activities like BMR, BPRs, logbooks and daily records.
- Qualification of production equipments and participation in validation activities.
- To check quality system in production department.
- To prepare equipment master list and equipment qualification plan.
- Review of MFRs, BMRs, BPRs, SOPs and formats.
- Review URS, DQ, IQ, OQ, PQ protocol with reports and validation protocol with reports.
- To ensure that all production deviations are reported, evaluated and that critical deviations are investigated, and the conclusions are recorded.
- Evaluation and investigation of all market complaints and necessary corrective and preventive actions jointly with QA.
- Initiating any change by originating change control request and to evaluate proposed changes in product,



process or equipment.
- Review proper segregation of material, labeling and identification, area cleaning and disinfection.
- Review Preventive maintenance and calibration done according to schedule of equipments/ utilities and recorded.
- Check on production yields and reconciliation at various stages of manufacturing.
- Responsible for giving training to the personnel working in the production area.
- Responsible for handling of manpower and proper allocation of manpower.
- Responsible for Internal audit preparation.
- Participate in external audit preparation and handling activities during audit.
- To comply the requirements of technical audit.
- cGMP documentation and their revision as and when required.
- Identifying need and procurement of recent machines and equipments.
- Resource identification (up gradation of existing equipments and manpower).
- Shift scheduling and sanctioning of product

📌 Production Head (Ankleshwar)
🏢 Real Placements
📍 Ankleshwar