Production Head- Injectable Production

Venus Remedies (VRL); Solan; On-site; INR 6,000,000 - 9,000,000; Full time

Job summary

Venus Remedies (VRL) seeks a seasoned AVP Technical Operations (Production - Injectables) to lead sterile manufacturing, ensure cGMP compliance, and drive continuous improvement across the site. You will oversee process validation, tech transfers, and regulatory inspections while building a high-performance team.

The role requires deep expertise in aseptic processes, quality culture, and strategic operations management for global markets.

Qualifications

• Bachelor’s or Master’s in Pharmacy or related field with GMP exposure.
• Advanced certifications in GMP/Quality/Lean Six Sigma preferred.
• 20–30 years pharma manufacturing experience with sterile injectables.

Responsibilities

• Lead end-to-end sterile production including filling, lyophilization and sterilization.
• Ensure cGMP, data integrity and aseptic best practices across site.
• Oversee regulatory inspections, audits and CAPA programs.
• Drive capacity expansion, tech transfers, and scale-up initiatives.
• Mentor teams; nurture GMP culture and safety standards.

Skills

Sterile manufacturing

GMP/compliance

Regulatory audits

Leadership

Process validation

Education

Bachelor/Master in Pharmacy

GMP/Lean Six Sigma certs

Tools

SAP/MES

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)