Job Description
- Support in production planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.
- Documentation Management, Preparation, Review & Approval of the SOP's, EOPs, IOPs. Area monitoring etc.
- Providing training to operators on SOP, EOP, IOP and process batch records.
- Preparation, Review, approval of URS, DQ, IQ, OQ and PQ of equipment’s/ instruments.
- Support for FAT, evaluation of equipment risk assessment, Assist in protocol preparation for Decommissioning of existing equipment’s and commissioning from at new facility.
- Support for entire plant Area validations, Qualification to meet projected timelines.
- Support in building, Implementation and following of cGMP requirements at all stages to meet compliance w.r.t. USFDA, EU, MHRA standards.
- Support in production planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.
- Monitoring and maintenance of equipment’s logbooks
- Purified water plant management and to ensure smooth functioning of water system.
- Training to Technicians on New equipment’s and instruments during installation.
- Support and co-ordination with various cross functional teams to meet project timelines.
- Raising indent for new instruments /equipment’s/ new accessories for day to day functioning of formulation development center.
- Work allocation to technicians in formulation development center.
- To monitor, control and handling of tooling and change parts for all equipment’s in Development lab and OSD pilot plant.
- To ensure implementation of EHS policy.
- Support in preparation of various client visits, regulatory and QP audits.
Management of change controls, incidents, deviations – investigations.
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