Trainee Officer

Amneal Pharmaceuticals


Date: 4 weeks ago
City: Hyderabad, Telangana
Contract type: Full time
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

Bachelor Degree with 3 years experience

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