Role & responsibilities

The AVP Technical Operations (Production – Injectables) will lead end-to-end sterile manufacturing operations for injectable dosage forms (SVP/LVP, Vials, Ampoules, PFS, Cartridges, Lyophilized products). The role is responsible for ensuring compliant, efficient, and cost-effective production aligned with global regulatory standards (USFDA, EU-GMP, MHRA, WHO, etc.), while driving operational excellence, quality culture, and continuous improvement across the site.

This position plays a critical leadership role in scaling capacity, managing regulatory inspections, technology transfers, and ensuring consistent delivery of high-quality sterile products to global markets.

Key Responsibilities

1. Production & Manufacturing Oversight
- Lead sterile manufacturing operations including compounding, filtration, aseptic filling, lyophilization, terminal sterilization, and visual inspection.
- Ensure adherence to cGMP, data integrity, and aseptic practices.
- Oversee production planning execution to meet OTIF (On-Time In-Full) delivery targets.




- Monitor batch cycle times, yield, OEE, and capacity utilization.
- Drive zero critical deviations and contamination control excellence.

2. Regulatory Compliance & Quality Assurance
- Ensure compliance with USFDA, EMA, MHRA, WHO, and other applicable regulatory authorities.
- Lead regulatory inspections, internal audits, and customer audits.
- Review and approve SOPs, batch manufacturing records (BMR), protocols, and validation documentation.
- Oversee deviation management, CAPA implementation, change control, and risk assessment processes.
- Ensure robust Environmental Monitoring (EM) and sterility assurance systems.

3. Technical Operations & Engineering
- Oversee equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and revalidation.
- Lead technology transfers for current products from R&D; or external sites.
- Support commissioning and scale-up of new sterile lines or facility expansion

📌 Production Injectable- AVP Technical (Baddi)
🏢 Venus Remedies (VRL)
📍 Baddi