Site Head - API Production
AI Summary
Lead API production site operations in Tripoli, Greece, ensuring safe, compliant and efficient manufacturing of sterile dry injections while driving strategy, capacity planning and team development in a GMP-regulated environment.
About this role
DEMO S.A., one of the leading pharmaceutical manufacturers in Europe, is looking for an experienced Site Head – API Production to lead its API manufacturing operations at our site in Tripoli, Greece.
The role requires strong expertise in sterile dry injections production and senior leadership experience in a GMP-regulated pharmaceutical manufacturing environment. This is a strategic opportunity designed for high-caliber pharmaceutical manufacturing professionals from India who are open to relocating to Greece and contributing to the growth of a key production hub.
Main duties and responsibilities:
- Lead the overall API production site operations, ensuring safe, compliant, efficient and uninterrupted manufacturing activity.
- Drive production strategy, capacity planning, resource allocation and execution of short- and long-term manufacturing plans.
- Ensure full compliance with applicable GMP requirements, including ICH Q7 principles for API manufacturing, internal quality standards and regulatory expectations.
- Partner closely with Quality Assurance, Quality Control, Engineering, Technical Services, Regulatory Affairs, Supply Chain and EHS to ensure operational alignment and inspection readiness.
- Monitor site performance through production KPIs, batch performance, deviations, yield, cycle times, cost, capacity utilization and continuous improvement initiatives.
- Lead and develop supervisors and cross-functional teams, building a culture of accountability, collaboration, performance and continuous improvement.
- Oversee technology transfer, scale-up, process optimization and validation-related activities in collaboration with technical and quality teams.
- Promote a strong safety culture and ensure that EHS standards, risk assessments and preventive actions are embedded in daily operations.
- Support audits, regulatory inspections, customer visits and remediation plans, ensuring timely and effective closure of actions.
- Act as a key site leadership representative, supporting strategic growth, organizational capability building and the successful development of API operations in Greece.
- Participate in the selection of the API production personnel, in collaboration with the HR recruitment Dept. and according to the Company’s Policies.
Requirements
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmacy or a related scientific field; postgraduate studies will be considered an asset.
- 10–15 years of experience in a similar senior API production leadership role within the pharmaceutical industry, with strong exposure to sterile dry injections and GMP-regulated manufacturing operations.
- Strong knowledge of API manufacturing operations, production planning, process equipment, batch records, deviations, CAPAs, change controls and validation principles.
- Solid understanding of international GMP standards for APIs, including ICH Q7 and regulatory inspection expectations.
- Proven experience leading production teams, developing managers and driving performance through KPIs and operational excellence practices.
- Experience in technology transfer, scale-up, process improvement or new product introduction will be highly valued.
- Strong decision-making, problem-solving and stakeholder management skills in complex manufacturing environments.
- Excellent command of English, both written and verbal.
- Availability to work in Tripoli, Greece.
Benefits
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
Skills
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