Production Injectable- AVP Technical

Venus Remedies (VRL); Solan; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Venus Remedies (VRL) seeks an AVP Technical Operations to lead sterile manufacturing for injectables in Solan, Himachal Pradesh. The role encompasses production oversight, regulatory compliance, and operational excellence to ensure high-quality products for global markets.

The ideal candidate should possess extensive experience (20-30 years) in pharmaceutical manufacturing and leadership in sterile injectables production, alongside a robust regulatory background. The position offers a dynamic work environment with flexible hours for critical production cycles.

Qualifications

• 20–30 years in pharmaceutical manufacturing.
• Minimum 8–10 years in sterile injectables production leadership.
• Proven experience handling USFDA/EU audits.

Responsibilities

• Lead sterile manufacturing operations ensuring compliance.
• Oversee regulatory inspections and quality assurance.
• Manage production budgets and optimize production efficiency.

Skills

Sterile manufacturing processes

Leadership in sterile injectables production

Regulatory compliance expertise

Operational excellence

Education

Bachelor’s / Master’s in Pharmacy, Chemical Engineering, Biotechnology

Advanced certifications in GMP/Quality/Lean Six Sigma

Tools

SAP/MES systems

Job description

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 new 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)