Job Purpose To ensure compliance with cGMP requirements during the manufacturing and packing of Oral Solid Dosage (OSD) and Sterilize injectable products through line clearance, in-process checks, documentation review, and monitoring of manufacturing activities.

Key Responsibilities

Production Area Monitoring

- Perform line clearance before the start-up of manufacturing and packing activities.

- Monitor dispensing, granulation, blending, compression, coating, capsule filling, and packing operations.

- Ensure adherence to approved Batch Manufacturing Records (BMR) and SOPs.

- Verify equipment status labels and cleanliness before use.

In-Process Quality Checks

- Conduct and record in-process checks as per approved specifications and frequencies.

- Monitor critical process parameters during manufacturing.

- Verify weight variation, hardness, thickness, friability, disintegration, and visual inspection results.

- Ensure proper sampling during various manufacturing stages.

Documentation & Compliance

- Review BMR/BPR entries for completeness and accuracy.

- Ensure Good Documentation Practices (GDP) are followed.

- Monitor adherence to cGMP, Data Integrity, and regulatory requirements.

- Issue, control, and reconcile manufacturing-related documents.

Line Clearance & Area Control

- Conduct area and equipment line clearance before and after batch processing.

- Verify removal of previous product materials and documents.

- Ensure proper status labeling and segregation of materials.

Quality Systems





- Participate in investigations related to deviations, incidents, OOS, and customer complaints.

- Support CAPA implementation and effectiveness verification.

- Assist in change control and risk assessment activities.

- Support internal, customer, and regulatory audits.

Sampling Activities

- Perform in-process, hold-time, and finished product sampling as per approved procedures.

- Coordinate with the QC department for sample testing and release activities.

Training & Continuous Improvement

- Provide GMP awareness and compliance support to production personnel.

- Participate in quality improvement initiatives.

- Support implementation of quality culture across manufacturing operations.

Qualifications

Education

- B.Pharm / M.Pharm

- Officer to Executive: 2-6 years of experience in IPQA activities within a pharmaceutical manufacturing facility.

Required Skills

- Knowledge of cGMP, GDP, and regulatory requirements.

- Experience with OSD manufacturing processes.

- Solid documentation and investigation skills.

- Knowledge of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).

- Familiarity with regulatory standards such as WHO-GMP, EU-GMP, USFDA, and MHRA.

- Good communication and coordination skills.

- Proficiency in MS Office.

Key Competencies

- Attention to detail

- Analytical thinking

- Problem-solving ability

- Quality mindset

- Team collaboration

- Regulatory compliance focus

Preferred Industry: Pharmaceutical

📌 Walk In Interview at Intas SEZ For ( IPQA - OSD and Injectable ) (Ahmedabad)
🏢 Intas
📍 Ahmedabad