Description:
Ther role is accountable for leading the design, development, implementation, and optimization of pharmaceutical manufacturing processes to ensure efficient, economical, scalable, and compliant mass production. The role provides strategic direction across process design, equipment layout, scale-up, and validation activities while ensuring regulatory compliance and product quality. This position drives process robustness, risk management, and operational excellence across the product lifecycle. The role partners with Manufacturing, Quality, R&D, and Engineering teams to enable technology transfer, continuous improvement, and data-driven decision-making. The role also ensures audit readiness, performance optimization, and sustainable manufacturing practices aligned with business and regulatory expectations.
Essential Functions:
- Lead process design, optimization, and manufacturing layout planning
- Oversee process scale-up, technology transfer, and commercialization activities
- Ensure regulatory compliance and GMP adherence across processes
- Govern process validation strategies, IQ/OQ/PQ, and master plans
- Drive deviation investigations, CAPA, and root cause analysis
- Monitor process KPIs, yields, and performance metrics
- Support equipment selection, installation, and automation integration
- Lead risk management, FMEA, and safety assessments
- Ensure quality, audit readiness, and inspection support
- Mentor teams and enable training and competency development
- Manage preventive maintenance of critical process equipments: RMG/FB/Fluid Bed Processor, Blenders, CAD Mill, Compression, Encapsulation, Auto‑coaters,
- Recommend vision systems and MES/eBR integration tools for process control
- Support in investigations for blend uniformity, weight variation, lamination/capping, sticking/picking, dissolution failures, friability/coating defects
Approve equipment URS, FAT/SAT and support IQ/OQ/PQ from a process perspective
Additional Responsibilities:
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
