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

following HODs instructions and guidance.

Qualifications

B.Pharmacy

Officer, Manufacturing Documentation

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