Senior Executive - Quality Assurance

What you become a part of:

What to expect:

• Preparation and timely updation of IPQA-related Standard Operating Procedures (SOPs) based on regulatory or operational requirements.
• Monitoring of raw material dispensing activities to ensure adherence to GMP practices and SOPs.
• Performing routine in-process quality assurance (IPQA) activities at designated frequencies, as defined in SOPs, and ensuring timely compliance of all IPQA observations.
• Conducting validation sampling as per the approved validation protocols and guidelines.
• Reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for accuracy, completeness, and readiness for dispatch.
• To check BSR and Shipper inspection as per SOP (as per requirement).
• Issuance, review, and reconciliation of formats for all departments.
• Issuance of BMR, BPR to the production department for processing of batch as per requisition received from production.
• Filing, labelling, and upkeep of documents in the document cell.
• To ensure cleaning, sanitation & hygiene in all departments and ensure all the time GMP compliance of plant.
• To handle IPQA team and related work allocation.
• To prepare monthly report of IPQA section related activity.
  

Essential education, experience and skills:

• B. Pharm and M. Pharm
• 8–10 years of experience in IPQA or Quality Assurance in a regulated pharmaceutical manufacturing environment.
• Should have exposure of SAP & ERP.
• Good understanding of cGMP, GLP, and regulatory requirements (e.g., USFDA, WHO, EU GMP).
• Proficiency in documentation practices, SOP handling, and batch record review.
• Strong attention to detail, ability to work in a team, and effective communication skills.
  

Application: