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.