Quality Control Lead

·       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

Place of work