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In-Process Quality Assurance Executive (IPQA)
We're Hiring: In-Process Quality Assurance Executive (IPQA)
The IPQA Executive will be responsible for ensuring adherence to Good Manufacturing Practices (GMP) during manufacturing and packaging processes of oncology formulations. The role involves real-time monitoring, documentation, and compliance checks to uphold product quality and regulatory requirements.
- Location: Shameerpet
- Department: Quality Assurance
- Qualification: B.Pharm / M.Pharm / M.Sc
- Experience: 2 to 5 Years (preferably in oncology manufacturing)
Key Responsibilities:
- Line Clearance:
Ensure line clearance is performed before starting manufacturing, packing, or batch processing activities.
Check cleanliness and status of equipment, area, and materials.
In-Process Checks:
Perform regular in-process checks during granulation, compression, coating, filling, and packaging stages.
Monitor parameters such as weight variation, hardness, thickness, uniformity, integrity, and label verification.
Batch Documentation Review:
Review BMRs/BPRs in real time to ensure entries are made as per SOP and GMP requirements.
Highlight deviations or discrepancies immediately.
Deviation & Change Control:
Identify, report, and document any process deviation.
Support in root cause analysis and implementation of CAPA.
Sampling Activities:
Responsible for IPC sampling, environmental monitoring samples, and in-process sample collection as per protocols.
Compliance & Audit Readiness:
Ensure readiness of production area for internal and external audits.
Ensure continuous GMP compliance in the oncology block.
SOP Compliance:
Ensure compliance with SOPs and provide suggestions for SOP improvements as necessary.
Train shop floor operators on GMP and data integrity.
Oncology-Specific Responsibilities:
Handle potent and hazardous oncology materials with safety and regulatory precautions.
Monitor isolator performance and containment measures in oncology production lines.
Key Skills Required
In-depth understanding of GMP and GLP
Knowledge of oncology product handling and containment
Attention to detail and documentation
Understanding of regulatory requirements (USFDA, EU, WHO, etc.)
Strong communication and observation skills
Ability to work in cleanroom and high-containment environments
Qualifications:
B.Pharm / M.Pharm / M.Sc
2 to 5 Years (preferably in oncology manufacturing)