Ipqa Executive

Job Title: IPQA - Quality Assurance

Company: Hester Biosciences Limited
Location: Merda - Ardraj, Taluka Kadi, District Mehsana, Gujarat 382721, India
Job Type: Full-Time
Working Hours: 9:00 AM 5:30 PM

Key Responsibilities:

• Coordinate with the Quality team for manufacturing processes of vaccines, diluents, and analytical methods.
• Ensure compliance with QA procedures at the manufacturing facility, including stability studies and reports.
• Conduct audits/inspections at CMOs for vendor qualification and compliance.
• Review CoAs to ensure alignment with product specifications and proper documentation of stability studies.
• Oversee batch documents and test analysis reports for compliance with established formulas and specifications.
• Implement quality systems such as change management, CAPA, complaint handling, and product recalls.
• Participate in failure investigations, product complaints, and process evaluations.
• Review and approve artwork (PPI & labels) for regulatory compliance.

Qualifications & Experience:

• Education:
• Bachelors in Pharmacy (B. Pharma), Masters in Life Sciences, or Master of Pharmacy (M. Pharm).
• Experience:
• 6-8 years of experience in the pharmaceutical or biopharmaceutical industry, preferably in therapeutics, vaccine manufacturing, biologics, or biosimilars.
• Experience in manufacturing (Mfg.), Quality Control (QC), and Quality Assurance (QA), specifically in in-process quality assurance, GMP documentation, and systems review is preferred.

Preferred Skills:

• Experience in the review of GMP documents, equipment, systems, and procedures.
• Strong understanding of the manufacturing process for vaccines and biologics.
• Familiarity with regulatory requirements and quality management systems in the pharmaceutical industry.

Benefits:

• Transportation: Company-provided transport to the plant.
• Canteen Services: On-site canteen facility.
• Holidays: 12 holidays per year.
• Weekend Off: First and third Saturdays, and Sundays.