Production Injectable- AVP Technical (Baddi)

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, productive, 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. 1. 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. 1. 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). 1. 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. 1. 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. 1. 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) Apply on Kit Job: kitjob.in/job/4n6n0q