Quality Control Lead
GSK
Full time- 10+ years
- Not Disclosed
- Nashik, India
- Post Date: Apr 18, 2024
- End Date: Jun 18, 2024
- 10+ years
- Not Disclosed
- Nashik, India
- Post Date:Apr 18, 2024
- End Date: Jun 18, 2024
Skills:
- pharma
- bpharm
- mpharm
Job Description:
Responsibilities
- 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 laboratories 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.
- Encourage staff for proactively identification of unsafe condition & unsafe behavior. Report it through ZAP process.
- Responsible for control on Chemical reagents and special hazards including sensitizers, Sensitizing and Biological agents
- Build an culture of reporting safety incidents and its closure within timeline with appropriate CAPA.
- To provide and support of EHS activities in Quality control.
- To ensure prevention of first aid cases/accident in department.
- To promote safety culture in Quality control department.
- To participate in RCAs as per requirement
- Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
- Drive improvement with an approach of Kaizen & CIF.
- To ensure continuous improvement in laboratory working and to impart working of QC staff
- Support the functional head to establish the activities assigned or identified “as and when basis.
- To provide authorization/approval of QC documents.
- Control on safekeeping of controlled substances in QC laboratory.
Qualification & Experience
- M.Sc /B.Pharm/ M.Pharm
- 12-15+ years experience in Pharmaceutical Plant, 10+ years in QC
- Acquaintance with respect to job requirements
-
Salary
Not Disclosed
-
Role
Executive or Officer
-
Area of Practice
- Quality Assurance/ Quality Control
-
Experience
10+ years
Remove this line later