Asst Manager QMS

Qualification :Msc chemistry/Bpharm/Mpharm

Experience – 4 to 10 Yrs

Location: Hyderabad (Choutuppal)

Job Description:

  • Coordinate with cross functional teams for the preparation and review of documents.
  • Check SOPs are available for all quality related activities and are current.
  • Prepare and reviewing procedures like SOPs, Specs, MOAs, AWS, PRPs, MFR, BMRs, forms etc.
  • Preparation of Level-I documents.
  • Documentation: To assist and implementation GMP documentation.
  • To review and approve master batch manufacturing record, Batch processing record & Batch Packing Record.
  • To assist and guide issuance of BMRs and BPRs for execution of batches as per the work order and regulatory requirements.
  • To enforce latest development in GMP, SOPs, BMRs & BPRs etc.
  • QMS: Evaluation and compliance of impact assessment of change control / Deviation related to facility and documentation.
  • To conduct and assist risk analysis, impact analysis, GAP analysis related to facility, deviation, Change control and mitigation of them.
  • Investigation of deviations, market complaints through various tools and maintain CAPA with adequate root cause investigations and compliance to scheduling and completion of resulting action items
  • Enter Deviations & OOS are investigated and necessary Corrective and Preventive actions in the log book.
  • Prepare internal audits schedule and necessary Corrective and Preventive actions as per internal audits.
  • Review and approval of validation protocols and reports.

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