Roles & Responsibilities

- Perform in-process quality checks during OSD manufacturing and packing activities.
- Conduct line clearance before batch start-up and after batch completion.
- Verify dispensing, granulation, blending, compression, coating, capsule filling, and packing operations.
- Ensure adherence to approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
- Monitor critical process parameters and record observations.
- Verify equipment cleanliness, status labels, and calibration status before use.
- Perform sampling of raw materials, in-process materials, bulk products, and finished products as per SOP.
- Monitor environmental conditions and ensure compliance with GMP requirements.
- Review batch records for completeness, accuracy, and compliance.
- Identify deviations, report non-conformances, and support investigation activities.
- Ensure Positive Documentation Practices (GDP) are followed throughout manufacturing.
- Monitor personnel hygiene, gowning practices, and cleanliness of production areas.
- Verify reconciliation of materials, labels, and packaging components.
- Participate in validation activities, process qualification, and media fills (where applicable).
- Support internal audits, customer audits, and regulatory inspections.
- Ensure compliance with current GMP (cGMP), data integrity, and regulatory guidelines.
- Coordinate with Production, QC,



Engineering, and Warehouse departments for smooth manufacturing operations.
- Handle change controls, CAPA implementation, and risk assessment activities.
- Maintain QA logs, checklists, and documentation.

Required Skills

- Knowledge of cGMP, GDP, and pharmaceutical quality systems.
- Understanding of OSD manufacturing processes.
- Familiarity with BMR, BPR, SOPs, deviations, CAPA, change control, and investigations.
- Experience in line clearance and in-process checks.
- Knowledge of regulatory requirements (WHO, USFDA, MHRA, EU GMP, PIC/S).
- Good observation, documentation, and communication skills.
- Ability to work in shifts and production environments.

Qualification

- B.Pharm / M.Pharm / (Chemistry, Microbiology, Life Sciences)

Experience

- 2-8years of experience in IPQA, OSD Manufacturing QA, or Pharmaceutical Quality Assurance.

Key Activities

- Line Clearance
- In-Process Checks
- BMR Review
- Sampling
- Documentation Review
- Deviation & CAPA Handling
- Equipment Verification
- Process Monitoring
- GMP Compliance
- Audit Support
- Batch Release Documentation Support

This job description is suitable for hiring IPQA Executives, Senior Executives, and Officers in OSD pharmaceutical manufacturing companies.Role & responsibilities

Preferred candidate profile

📌 Ipqa Executive (Assam)
🏢 The Pharma Patashala
📍 Assam