Officer Manufacturing Documentation

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

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