Greeeting form BVR People Consuling

Job Title: Manager - Quality Assurance (Sterile Injectables)

Education : MSc (Chemistry), M.Pharma

Experience: 15+ Years ( Injectable )

Location: Chennai

Role Overview

We are seeking an experienced Sterile QA Manager to lead quality assurance operations for our USFDA-approved liquid and lyophilized injectable manufacturing facility. The position oversees cleanroom validation, aseptic IPQA floor operations, QMS investigations, and regulatory audit readiness (USFDA, EU-GMP, WHO-GMP).

Key Roles & Responsibilities

- Cleanroom Validation & Sterility Assurance: Drive cleanroom qualification (Grade AD / ISO 14644 / Annex 1), HEPA filter integrity (DOP testing), differential pressure cascades, smoke studies, and environmental monitoring (EM) trends.
- Aseptic Operations & Media Fills: Oversee Aseptic Process Simulations (Media Fills), gowning qualifications, stopper bowl setups, and sterile line clearance.
- IPQA Floor Oversight: Direct real-time IPQA teams across liquid filling, lyophilization loading/unloading, capping, terminal sterilization, and CCIT testing.
- QMS & Investigations: Lead site QMS events, including Deviations, CAPA,



Change Controls, OOS/OOT investigations, and Quality Risk Management (QRM / ICH Q9).
- Equipment & Utility Validation: Review protocols (DQ/IQ/OQ/PQ) for filling lines, autoclaves, depyrogenation tunnels, HVAC systems, and WFI/Pure Steam utilities.
- Batch Release & Data Integrity: Authorize finished batch disposition in SAP in compliance with ALCOA+ data integrity guidelines.
- Regulatory Audits: Lead inspection readiness and defend QA systems during major global regulatory audits (USFDA, EU-GMP, MHRA).

Candidate Requirements

- Education: M.Pharm / B.Pharm / M.Sc in Pharmaceutical Sciences or related field.
- Experience Mandate: 15+ years of core experience in Sterile Injectable / Parenteral manufacturing plants. (Note: API-only or Solid Oral backgrounds will not be considered).
- Technical Skills: Hands-on expertise in EU GMP Annex 1, USFDA 21 CFR 210/211, TrackWise, SAP, and Media Fill execution.

Intrested Candidates share your CV to [email protected] OR (phone hidden)

Regards

Dinagaran R

📌 Manager - QA - Sterile - Loc : Chennai (Chengalpattu)
🏢 BVR People Consulting
📍 Chengalpattu