Job Description
To follow the safety rules in the premises according to the company norms.
- To handle Quality Management Documents like Change Control, Deviation etc
- To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and
Non-Conformances.
- To ensure investigations are evaluated and closed out in a timely manner to meet business needs.
- Responsible for cGMP compliance related to CAPA implementation and to ensure the timely closure of
CAPA.
- To review, develop and introduce systems, practices and cultural changes that enable the department to
meet business demands within agreed time frames and expected GXP standards.
- To perform risk analysis for different process or procedures and implement necessary mitigation plans
through Quality Risk Management (QRM).
- To provide direct input or coaching support for other functional groups in investigations.
- To conduct internal audits as per laid down schedule with different function.
- To prepare and review of Standard Operating Procedures / Protocols.
- To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record /
Standard Operating Procedure / Protocol and initiation of corrective actions.
- To participate in Regulatory & Customer Audits.
- To evaluate & investigate Market complaints.
- To provide training to subordinates for different processes / procedures.
- Responsible for intra and inter coordination with different functions.
- To prepare BMR and BPR.
- Timely completion of allotted Sop s training.
- Preparation and periodic revision of SOPs related to QMS area.
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by