Quality Assurance Executive

Intas; Sanand; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Intas in Gujarat is seeking an Executive Quality Assurance (Parenteral) to ensure GMP compliance in sterile manufacturing. The role involves line clearance, in-process checks, and audits of BMR/BPR and production records, with support for validation activities and batch release coordination.

The candidate should have 5–8 years of QA experience in a sterile/parenteral facility, with B.Pharm / M.Pharm / M.Sc education.

Qualifications

• 5–8 years of QA experience in a sterile/parenteral pharma facility.
• Experience ensuring GMP compliance in sterile manufacturing.
• Experience with line clearance, in-process checks, and audits.

Responsibilities

• Ensure GMP compliance in sterile/parenteral manufacturing operations.
• Perform line clearance, in-process checks, and area audits.
• Review BMR/BPR, logbooks, and production records for compliance.
• Support validation activities (Process, Cleaning, Equipment, Media Fill).
• Conduct batch review and coordinate batch release activities.
• Participate in self-inspections, regulatory audits, and customer audits.

Skills

QA in sterile parenteral

Quality systems

Audit support

Education

B.Pharm / M.Pharm / M.Sc

Tools

BMR/BPR review tools

Job description

Executive Quality Assurance (Parenteral)

Key Responsibilities

• Ensure GMP compliance in sterile/parenteral manufacturing operations.
• Perform line clearance, in-process checks, and area audits.
• Review BMR/BPR, logbooks, and production records for compliance.
• Support validation activities (Process, Cleaning, Equipment, Media Fill).
• Conduct batch review and coordinate batch release activities.
• Participate in self-inspections, regulatory audits, and customer audits.

Education and Experience

• Education: B.Pharm / M.Pharm / M.Sc
• Experience: 5 to 8 years in QA of a sterile/parenteral pharmaceutical facility.