Job Description

Job Purpose

To ensure compliance with cGMP and regulatory requirements during manufacturing, packing, and in-process activities, by effective implementation of IPQA systems, documentation review, and continuous monitoring of shop-floor operations.

Key Responsibilities

1. In-Process Quality Assurance

Ensure line clearance before start, during changeover, and after completion of manufacturing/packing activities

Monitor critical process parameters (CPPs) and critical quality attributes (CQAs)

Verify adherence to BMR/BPR during execution

Ensure proper status labeling and material movement control

2. GMP Compliance

Ensure compliance with WHO-GMP / Schedule M / USFDA / EU-GMP as applicable

Conduct regular shop-floor GMP audits

Identify deviations, non-conformances, and initiate corrective actions

3. Documentation & Review

Review and approve:

o Batch Manufacturing Records (BMR)

o Batch Packing Records (BPR)

o Logbooks and in-process records

Ensure timely closure of deviations, incidents, and OOS/OOT

Review change controls related to manufacturing and packing

4. Deviations, CAPA & Investigations

Initiate and investigate deviations, incidents, and market complaints

Prepare and implement CAPA with defined timelines

Track effectiveness of CAPA

5. Validation & Qualification Support

Support process validation, cleaning validation, and equipment qualification

Review validation protocols and reports from IPQA perspective

6. Training & Team Management

Train IPQA officers/executives on:

o GMP practices

o SOPs

o Regulatory expectations

Allocate duties and monitor team performance

7. Regulatory & Audit Support

Support internal audits, customer audits, and regulatory inspections

Prepare and review responses to audit observations related to IPQA

8. SOP Management

Prepare, review, and implement SOPs related to IPQA activities

Ensure SOP compliance on the shop floor

Authority

To stop manufacturing/packing activity in case of critical GMP non-compliance

To approve/reject in-process activities as per quality standards

To recommend corrective and preventive actions

Qualification & Experience

B.Pharm / M.Pharm / M.Sc (Chemistry or relevant discipline)

8-12 years of experience in IPQA in pharmaceutical manufacturing

Exposure to regulatory audits (WHO, USFDA, EU, etc.) preferred

Skills & Competencies

Strong knowledge of cGMP, Schedule M, and regulatory guidelines

Excellent documentation and investigation skills

Leadership and team-handling ability

Good communication and coordination with Production, QC, and Engineering

Problem-solving and decision-making skills

Key Performance Indicators (KPIs)

Reduction in deviations and repeat observations

Timely batch release support

Audit compliance and inspection outcomes

Effective CAPA implementation

Job Types: Full-time, Permanent

Pay: From ?100,000.00 per month

Benefits:

Cell phone reimbursement Food provided Paid sick time Paid time off
Work Location: In person