Summary
- Plays a key role in startup and operational readiness of the aseptic manufacturing facility with multiple production line.
- Responsible for supporting and executing daily operational inspection activities
- Plays an active role in New Product Introduction (NPI) programs for multiple products, which includes supporting technology transfer activities, execution of engineering and commercial batches, process validation, inspection and packaging trials.
Role and Responsibilities
- Lead startup, commissioning, qualification, validation, and operational readiness for Assembly, Visual Inspection, and Packaging operations.
- Provide technical and operational leadership to ensure safe, compliant, and efficient manufacturing execution.
- Oversee equipment lifecycle management, including qualification, validation, maintenance, troubleshooting, and continuous improvement.
- Drive visual inspection programs, defect management, POD studies, QRA assessments, and process optimization.
- Lead engineering runs, media fills, process validation, PPQ, and commercial manufacturing activities.
- Collaborate with cross-functional teams to support NPI, technology transfer, process improvements, and product lifecycle management.
- Ensure compliance with cGMP, FDA, EMA, PIC/S, ICH, Annex 1, and customer requirements while maintaining inspection readiness.
- Lead investigations, deviations, CAPAs, risk assessments, and Change Controls to ensure product quality and compliance.
- Drive operational excellence through performance monitoring, productivity improvements, quality enhancement, and cost optimization.
- Review and approve GMP documentation, including SOPs, batch records, protocols, reports, and training materials.
- Oversee QMS activities, audits, inspections, data integrity, and regulatory commitments.
- Manage department resources, project timelines, and production priorities to meet business objectives.
- Serve as a key contact for customers, auditors, and regulatory authorities.
- Coach and develop teams while promoting a culture of safety, quality, compliance, and continuous improvement.
- Provide leadership during critical manufacturing operations, validation campaigns, and regulatory inspections.
- Accountable for overall operational, technical, quality, compliance, and business performance.
Qualification
- Bachelor's Degree in Engineering, Pharmaceutical Sciences, Life Sciences or any related discipline
- At least 5 years in drug product manufacturing, particularly visual inspection and packaging operations.
- Strong knowledge of cGMP and global regulatory requirements (FDA, EMA etc)
- Strong expertise in visual inspection programs (defect management, POD studies, QRA etc)
- Strong technical, analytical, troubleshooting, root cause investigation and cross-functional collaboration capabilities.
- Proficient in manufacturing systems (eBR, SAP/ERP platform, data analysis tools)
