Job Description

Department:

Quality Assurance

Reporting To:

Manager - QA / Production

Experience:

2-5 Years

Qualification:

B.Pharm / M.Pharm / B.Sc. / M.Sc.

Shift:

Three-shift operation

Job Summary

Responsible for monitoring manufacturing activities to ensure compliance with

cGMP, SOPs, and regulatory requirements

. The role involves line clearance, in-process monitoring, batch record verification, and accurate documentation to ensure consistent product quality and regulatory compliance.

Key Responsibilities

Monitor and supervise

manufacturing activities

in accordance with

cGMP, approved SOPs, and regulatory guidelines

. Perform

line clearance

before start-up, during changeovers, and after batch completion. Verify and review

Batch Manufacturing Records (BMR)

and

Batch Packing Records (BPR)

for accuracy, completeness, and compliance. Ensure all manufacturing operations are executed strictly as per

approved MFR (Master Formula Record)

. Perform and document

in-process checks (IPC)

during various stages of manufacturing. Ensure timely and accurate

documentation of manufacturing activities

in logbooks, batch records, and related formats. Identify, document, and escalate

deviations or non-conformances

to QA/Production management. Ensure adherence to

data integrity

and

GDP practices

during documentation. Coordinate with Production, QA, and QC teams to maintain smooth manufacturing operations. Work effectively in

three-shift operations

as per production requirements. Support internal and external

audits and inspections

related to manufacturing activities.

Key Skills & Competencies

Strong knowledge of

cGMP and regulatory requirements

Hands-on experience in

line clearance and in-process monitoring

Sound understanding of

BMR, BPR, and MFR

Good documentation and compliance orientation Attention to detail and analytical skills Ability to work in

rotational shifts

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹45,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person