Officer, Quality Assurance

Job Description

JOB DESCRIPTION

This role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams

Key Responsibilities

Ensure adherence to cGMP and GDP practices during all in-process activities.

Perform line clearance checks before starting production and packaging operations.

Monitor and verify critical manufacturing and packaging parameters as per approved BMR / BPR.

Review and ensure compliance with SOPs, protocols, and regulatory guidelines .

Verify sampling, labeling, and dispensing of raw materials and intermediates.

Perform in-process checks and record observations in real-time.

Ensure timely identification, documentation, and escalation of any deviations, OOS, OOT, or incidents .

Support QA team in investigations and CAPA implementation .

Participate in internal audits, regulatory inspections, and compliance activities .

Maintain effective communication with Production, QC, and QA teams for smooth operations.

Ensure that all activities are performed safely and in accordance with company policies.

Skills & Competencies

Strong knowledge of cGMP, GDP, and regulatory compliance .

Hands-on experience in API manufacturing processes .

Good understanding of QA / QC procedures.

Strong communication and interpersonal skills for cross-functional coordination.

Documentation accuracy and attention to detail.

Ability to work in a fast-paced manufacturing environment.

Qualifications

Qualification : M.Sc. (Chemistry / Pharmaceutical Sciences)

Experience : 2 to 4 Years (API industry experience mandatory)

Additional Responsibilities

Conduct periodic shop floor rounds to ensure compliance with cGMP and safety practices.

Provide on-the-job training to production personnel on documentation and quality practices.

Support preparation and review of SOPs, protocols, and batch records .

Monitor and control environmental conditions in production areas (temperature, pressure differentials, cleanliness).

Ensure timely closure of deviations, CAPA, and change controls related to IPQA activities.

Support technology transfer and validation activities from a QA perspective.

Assist in review of batch manufacturing records (BMR) and batch packaging records (BPR) for completeness and compliance.

Act as QA representative during regulatory and customer audits .

Contribute to continuous improvement initiatives in QA and manufacturing processes.

Skills Required

Technology Transfer, Capa, Regulatory Compliance, Sops, Cgmp, deviations , batch records