Job Title: Executive / Senior Executive – In-Process Quality Assurance (IPQA)
Company Overview:
Join a leading biopharmaceutical division of a renowned pharmaceutical company, committed to excellence in quality and innovation. We are currently expanding our Quality Assurance team and seeking dedicated professionals who are passionate about maintaining the highest standards in pharmaceutical manufacturing. Our focus on cutting-edge biopharma products demands meticulous attention to detail and a robust understanding of quality systems.
About the Role:
We are looking for experienced and highly motivated individuals to join us as Executive or Senior Executive in our In-Process Quality Assurance (IPQA) department. This crucial role will be based at our state-of-the-art facility in Ahmedabad. Successful candidates will play an active role in ensuring the quality and compliance of our biopharmaceutical products, with a particular emphasis on manufacturing processes within aseptic and sterile environments. You will be instrumental in upholding our commitment to quality and regulatory excellence.
Key Responsibilities:
As an Executive/Senior Executive – IPQA, your responsibilities will include:
- Ensuring strict adherence to Good Manufacturing Practices (GMP) and conducting thorough line clearances before and during production.
- Performing hands-on quality assurance activities directly on the shop floor to monitor compliance and process integrity.
- Reviewing and compiling Annual Product Quality Reviews (APQR) and Continuous Process Verification (CPV) reports to assess product lifecycle performance.
- Meticulously reviewing Batch Manufacturing Records (BMR) for accuracy, completeness, and compliance with established procedures.
- Actively managing deviations, initiating investigations, and ensuring timely implementation of corrective and preventive actions.
- Providing essential support during internal and external regulatory audits and inspections, ensuring readiness and effective communication.
Qualifications:
- A minimum of 5 to 10 years of relevant experience in an IPQA role within the Pharmaceutical or Biopharmaceutical manufacturing industry.
- Mandatory experience in aseptic and sterile product manufacturing is required for this position.
- Strong theoretical and practical knowledge of In-Process Quality Assurance (IPQA), Good Manufacturing Practices (GMP), Annual Product Quality Review (APQR), Continuous Process Verification (CPV), and comprehensive Quality Systems.
- Proven hands-on experience on the shop floor, demonstrating an ability to apply quality principles in a dynamic manufacturing environment.
- Excellent communication skills and the ability to collaborate effectively within a team-oriented setting.
Location: Ahmedabad
How to Apply:
If you possess the required expertise and are eager to contribute to a dynamic and growing organization dedicated to pioneering biopharmaceutical solutions, we encourage you to apply. Please submit your updated resume and a cover letter detailing your relevant experience and qualifications for this role.
