Senior Executive, IPQA EM

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals seeks an IPQA professional to ensure cGMP compliance on manufacturing and packaging shop floors for injectable products. You will perform in‑process QA activities, monitor real‑time operations, review documentation, and support batch releases with strong adherence to quality standards.

The role requires 2–4 years of in‑process QA experience, a Master’s in Microbiology, and expertise in deviations, CAPA, and line clearance. Excellent written and verbal English is essential.

Qualifications

• Master's degree in Microbiology or related field.
• 2–4 years of in‑process quality assurance experience in pharmaceutical or related environment.
• Strong knowledge of cGMP, regulatory compliance, and IPQA practices.

Responsibilities

• Real‑time monitoring on manufacturing shop floor and packaging areas to ensure cGMP compliance.
• Review online documents and records (logbooks, logs, batch records) for accuracy and completeness.
• Calibrate IPQA instruments and supervise dispensing activities on shop floor.
• Provide on‑the‑job training to staff on GMP practices and documentation.

Skills

IPQC mastery

Compliance & regulatory knowledge

Aseptic process monitoring

Line clearance & batch review

Deviation CAPA management

In-process checks & monitoring

Change control management

Equipment & facility knowledge

Root-cause analysis

Analytical QA

Education

Master's degree in Microbiology

Job description

Mandated compliance with cGMP and regulatory mandates by performing in‑process QA activities on the manufacturing and packaging shop floor to support the production of high‑quality injectable pharmaceutical products. Responsibilities include real‑time monitoring, documentation review, sampling, and area/machine clearances.

Essential Functions

• Ensure cGMP compliance review on manufacturing shop floor and packaging areas.
• Supervise dispensing activity on manufacturing shop floor and packaging areas.
• Issue bottle labels, outser, and medication guides for commercial batch.
• Responsible for providing machine and area clearance.
• Conduct sampling of reserve, stability, and in‑process checks during batch packaging execution as per BPR and stability study protocol.
• Review online documents and records such as equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration records, and batch records.
• Calibrate IPQA instruments.

Additional Responsibilities

• Real‑time monitoring and compliance reporting.
• Participate in investigations.
• Provide on‑the‑job training to shop‑floor personnel on GMP practices, quality standards, and documentation practices.
• Maintain IPQA‑related documents and records in audit‑ready state.
• Employ strong written and verbal communication skills in English.

Qualifications

Education

• Master's Degree (MS/MA) in Microbiology.

Experience

• 2‑4 years in‑process quality assurance in the pharmaceutical or related environment.

Skills

• IPQC mastery.
• Compliance and regulatory knowledge – advanced.
• Aseptic process monitoring & compliance – advanced.
• Line clearance & batch record review – mastery.
• Deviation, investigation & CAPA management – advanced.
• In‑process checks & monitoring – advanced.
• Deviation & change control management – advanced.
• Equipment & facility knowledge – advanced.
• Investigation skills for root‑cause analysis – advanced.
• Analytical QA – advanced.