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

1. 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

1. 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

1. Deviations, CAPA & Investigations

· Initiate and investigate deviations, incidents, and market complaints · Prepare and implement CAPA with defined timelines

· Track effectiveness of CAPA

1. Validation & Qualification Support

· Support process validation, cleaning validation, and equipment qualification · Review validation protocols and reports from IPQA perspective
1. Training & Team Management

· Train IPQA officers/executives on:



o GMP practices o SOPs o Regulatory expectations

· Allocate duties and monitor team performance

1. Regulatory & Audit Support

· Support internal audits, customer audits, and regulatory inspections · Prepare and review responses to audit observations related to IPQA
1. 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: ₹20,000.00 - ₹35,000.00 per month

Advantages

- Cell phone reimbursement
- Food provided
- Paid sick time
- Paid time off

Work Location: In person

📌 IPQA Officer (Vadodara)
🏢 Elysium Pharmaceuticals
📍 Vadodara