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 recent products from R&D; or external sites.

- Support commissioning and scale-up of new sterile lines or facility expansions.

- Drive automation, digital manufacturing initiatives, and MES implementation (if applicable).

4. Operational Excellence & Continuous Improvement

- Implement Lean, Six Sigma, and operational excellence frameworks.

- Optimize manpower productivity and reduce operational costs.

- Improve Right First Time (RFT), reduce batch failures and deviations.

- Implement contamination control strategy (CCS) and lifecycle validation programs.

5. People Leadership & Development

- Lead, mentor, and develop production, engineering, and validation teams.

- Build strong GMP and quality-driven culture across departments.

- Establish succession planning and competency development programs.

- Ensure adherence to EHS standards and promote safe working practices.

6. Financial & Strategic Responsibilities

- Manage production budgets, CAPEX, and OPEX.

- Drive cost optimization initiatives without compromising compliance.

- Support strategic planning for capacity expansion and new product introduction.

- Participate in make-vs-buy decisions and contract manufacturing evaluations.

Key Performance Indicators (KPIs)

- Zero critical regulatory observations

- Batch rejection rate

- OEE improvement %





- Deviation closure timelines

- OTIF performance

- Cost per batch reduction

- Audit readiness score

- Environmental Monitoring compliance trends

Qualifications & Experience

Education:

- Bachelor’s / Master’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.

- Advanced certifications in GMP/Quality/Lean Six Sigma preferred.

Experience:

- 20–30 years in pharmaceutical manufacturing.

- Minimum 8–10 years in sterile injectables production leadership.

- Proven experience handling USFDA/EU audits.

- Experience in large-scale aseptic manufacturing facility.

Technical Competencies

- Sterile manufacturing processes (aseptic & terminal sterilization)

- Lyophilization process understanding

- HVAC & cleanroom management

- Contamination control strategy

- Media fills & aseptic process simulation

- Process validation lifecycle

- Risk management (ICH Q9)

- Data integrity principles

- SAP/MES systems exposure

Behavioral Competencies

- Strategic thinker with operational depth

- Strong regulatory and compliance mindset

- Decisive leadership under pressure

- Cross-functional collaboration

- Crisis management capability

- High ownership and accountability

Preferred Experience

- Exposure to PFS and Cartridge filling lines

- Experience in biologics injectables (desirable)

- Greenfield project or facility expansion leadership

- Global stakeholder management experience

Working Conditions

- Sterile manufacturing environment (Grade A/B/C/D areas)

- Flexible working hours during audits or critical production cycles

- Travel for regulatory interactions or corporate meetings (if applicable)

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