Job Description

Position: Manager - 2
Grade: G11A
Department: Quality Control
Education Qualification: B.Pharma /M.Pharma
Years of Experience: 12+ Years
Job Role: Lead Packaging material & GLP (QC Lab/PM Lab/Micro Lab) sections
Responsibilities

• Ensure timely sampling, testing and release of all Raw materials and packaging materials as per approved specifications, STP's and customer requirements.
• Coordinate and prioritize sampling/testing with the Production scheduler/Manufacturing department and schedule QC coverage as necessary to support manufacturing activities for minimizing delays.
• Manage resource planning, monitoring and control of manpower with organogram preparation.
• Equipment usage, facilities, spares and maintenance of instruments and equipment in the lab and sampling area to accomplish workload requirement.
• Ensure timely work planning and allotment of work to Packaging materials sampling and testing team and pre-purchase testing and release activities Review of Annual product review data.

• To approve record of analysis, CoAs
• Preventive maintenance and calibration of instruments and equipment in the Laboratory
• IQ, OQ, PQ, RQ of the instruments and equipment and approval of related documents.
• Installation and validation activities pertaining to the software used in the Laboratory.
• Liaising for the activities pertaining to procurements of instruments, equipment and its components for ensuring regulatory compliance.
• Monitor backup activities related to laboratory instruments and software.
• Monitor the overall laboratory compliance in the following area.
• Ensure compliance of cGxP and applicable safely requirements in the QC laboratory.
• Ensure timely revision, implementation & availability of Standard Operating Procedure, Standard Test Procedure, Specification and General Procedure & being followed effectively.