Opening For Quality Assurance Profile at Ranjangaon

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.