Quality Control Lead

3 weeks ago

Nashik, Maharashtra, India Antal International Full time
Job Description

· To ensure testing and release of raw material ,excipient, packing material, microbiological sample, bulk and finished product.

· To ensure stability program conducted as per protocol

· To support validation team for process validation samples analysis management

· To ensure qualification, calibration and maintenance of all laboratory's instruments

· To ensure OOS investigation and reporting in time

· Control on lab. Related SOPs/PQS/PMSP –Reviews as per schedule

· Control on Reference standards management require for QC Laboratories

· To ensure CAP/ATS compliance

· To ensure that the activities in the QC Lab are in compliance with regulatory requirements

· To ensure Compliance and inspection readiness

· Verify compliance to Good Laboratory practice and Schedule L1of D & C act

· To conduct initial assessment of change control raised in area of operation

· Ensure monthly L1 audit of EHS/Quality as per schedule to identify gaps & timely closure of actions.

· Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audit and WHO audits

· Tracking of staff leave and promote for plan absenteeism. Unplanned absenteeism cases to be handle as per standard procedures.

· One on one discussion with staff to maintain discipline and building their capabilities.

· Coaching/counseling of staff for adherence to standards related to safety, quality & delivery.

· Quarterly Performance discussion with staff and ensure recording of NMS performance in PDP card.

· Coordination & monitoring of dept consumables & inventory.

· Handling of electronic systems (e.g. Empower,MERP, VQD, VQMS, SLIMS etc.)

· Resource management of laboratory to have smooth work function department is done in time.

· Ensure procurement for item required for quality department is done in time

· Site SQCS contact; ensure adequate QC support in vendor approval process. Timely analysis of purchase samples.

· To complete the QMS training in time and ensure the compliance with QMS in your area of operation. To carry out the gap analysis as per the requirement.

· To ensure SOPs for area are under control are valid and meets all regulatory and QMS requirements

· Risk management for department, Control on risk Log, Preparation of STPs and tracking of risks.

To ensure monthly EHS meeting are happening, and issues are discussed and sorted

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