Walk In Interview at Intas SEZ For ( IPQA - OSD and Injectable )

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.
• Strong 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