Opening For Quality Assurance Profile at Ranjangaon

1 week ago

Pune, Maharashtra, India Tulip Lab Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Key Roles and Responsibilities

1. Documentation and Record Management

  • Prepare Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).
  • Prepare and maintain Process Validation Protocols, Process Validation Reports, and Stability Protocols.
  • Prepare Maximum Hold Time Study Protocols and maintain the Hold Study Program.
  • Maintain the Change History of all controlled documents and records.
  • Issue and track BMRs, BPRs, SOPs, formats, and registers to the concerned departments.
  • Perform batch reconciliation and review of executed BMRs and BPRs.

2. Validation and Qualification

  • Review and approve method validation data, stability protocols, and sampling protocols.
  • Review and monitor validation activities including process, cleaning, and equipment validation.
  • Ensure Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of laboratory instruments (e.g., HPLC, GC, FT-IR).
  • Prepare and review documents like the Validation Master Plan (VMP) and Qualification Documents.

3. Coordination and Communication

  • Coordinate with R&D, Production, Stores, and Engineering departments for smooth documentation and compliance.
  • Coordinate with Loan License (LL) parties regarding product manufacturing activities.
  • Verify reference samples and Certificates of Analysis (COA) for LL products and provide clearance.
  • Maintain records of reference samples, COAs, and correspondence related to LL parties.

4. Quality System and Compliance

  • Monitor shop floor activities to ensure adherence to cGMP and GLP standards.
  • Ensure calibration of all equipment and instruments as per defined schedules.
  • Ensure readiness for ATR (All-Time Readiness) audits and inspections.
  • Maintain discipline and ensure compliance with GMP in all plant areas.
  • Check, review, and approve documentation such as Change Control, Deviation Reports, Market Complaints, and Product Recall documents.
  • Review and monitor self-inspection and internal audit activities.
  • Conduct vendor audits as per approved schedules.
  • Review and approve Quality Management System (QMS) documents, Site Master File (SMF), and Validation Master Plan (VMP).

5. Data Review and Analysis

  • Review raw data, protocols, STPs, and COAs as per GMP requirements.
  • Review trend analysis reports and Annual Product Reviews (APR).
  • Ensure analytical protocols are prepared as per relevant pharmacopoeial requirements.

6. Continuous Improvement and Management Support

  • Implement overall cGMP practices in the plant to ensure Quality, Safety, and Efficacy of products.
  • Perform additional tasks as assigned by seniors or management.

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