HYDERABAD · FULLTIME
QA IPQA (OSD)

Sri Ambikare Pharma
Hyderabad · onsite · Posted 12d ago
Sourced from
Not disclosed3–5 yrsfulltimeHyderabad
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Section · 01
About this role
. QA – IPQA (OSD)
Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry
Experience: 3–5 years
Department: Quality Assurance
Core Area: IPQA – Pellets/OSD
Vacancies: 6
Email ID :[HIDDEN TEXT]
Job Description
- Perform in-process quality assurance activities for Pellets/OSD manufacturing operations such as dispensing, sifting, granulation, drying, blending, coating, and packing.
- Monitor manufacturing activities to ensure compliance with GMP, SOPs, BMR/BPR and approved procedures.
- Perform line clearance before starting manufacturing and packing activities.
- Verify dispensing of raw materials and packaging materials as per approved documents.
- Monitor and verify critical process parameters such as:
- Dispensing, Sifting, Granulation, LOD/moisture, Particle Size, Blend time, Coating parameters
- Review and verify Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
- Ensure proper documentation and Good Documentation Practices (GDP).
- Report and document deviations, incidents, OOS/OOT and process-related abnormalities.
- Participate in CAPA, change control and investigation activities.
- Perform shop-floor audits and ensure compliance with GMP requirements.
- Verify equipment cleaning and cleaning-status labels.
- Ensure proper identification and status labeling of materials, equipment and products.
- Coordinate with Production, QC, Warehouse and other departments for quality-related activities.
- Support batch release documentation and QA review.
- Ensure compliance with applicable regulatory and company requirements.
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Section · 02
Skills
shop-floor auditsbprSOPsCAPAChange ControlIn Process Quality AssuranceBmrGMP