Process Quality Assurance; IPQA Specialist – Sterile Injectables

The In-Process Quality Assurance (IPQA) Specialist is responsible for ensuring compliance with cGMP requirements during the manufacturing of sterile injectable products. The role involves real-time quality monitoring, batch documentation review, in-process sampling, line clearance, and support for batch release activities to ensure product quality, safety, and regulatory compliance.

• Perform in-process quality assurance activities for sterile and injectable manufacturing operations in compliance with cGMP, regulatory guidelines, and internal SOPs.
• Ensure proper line clearance before initiation and after completion of manufacturing and packing activities.
• Conduct in-process checks and sampling during manufacturing, filling, and packaging of sterile products.
• Review and prepare Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for accuracy, completeness, and compliance.
• Participate in batch release activities
  , including review of manufacturing, packaging, and quality documents.
• Review and support preparation of Annual Product Quality Review (APQR) reports.
• Monitor and ensure adherence to aseptic practices, cleanroom behavior, and environmental control requirements
  .
• Identify, document, and support investigations related to deviations, OOS/OOT, change controls, and CAPA related to in-process activities.
• Ensure compliance with regulatory standards (USFDA, EU GMP, WHO, etc.) during shop‑floor operations.
• Coordinate with Production, QC, Engineering, and other cross‑functional teams to resolve quality issues.
• Support internal and external audits and regulatory inspections by providing documentation and responses related to in-process QA activities.
• Maintain and update SOPs and QA documentation as required.

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Microbiology, or a related science discipline
  .
• Minimum 5 years of experience in In‑Process Quality Assurance within sterile / injectable pharmaceutical manufacturing.
• Strong hands‑on experience in sterile operations
  , aseptic filling, and injectable dosage forms.
• Proven experience in BMR/BPR preparation and review
  , APQR
  , batch release
  , line clearance
  , and in‑process sampling
  .
• Good understanding of cGMP, data integrity, and regulatory compliance requirements.
• In-process QA operations for sterile products
• Injectable manufacturing knowledge
• Documentation review and compliance
• Regulatory audit readiness
• Deviation handling and CAPA management
• Strong attention to detail
• Effective communication and coordination skills