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Site Head - API Production

Demo S.A. · Tripoli

New
Senior 🇬🇧 English
GMP ICH Q7 CAPA Change control Validation Technology transfer Scale-up

Job description

About the role

Demo S.A., a leading European pharmaceutical manufacturer, is looking for an experienced Site Head of API Production to lead its API manufacturing operations at its site in Tripoli, Greece. The role suits senior pharmaceutical manufacturing professionals from India who are open to relocating to Greece. It calls for strong expertise in sterile dry injections production and senior leadership experience in a GMP-regulated environment.

Key responsibilities

  • Lead overall API production site operations, keeping manufacturing safe, compliant, efficient and uninterrupted.
  • Drive production strategy, capacity planning, resource allocation and short- and long-term manufacturing plans.
  • Ensure compliance with GMP requirements, including ICH Q7, internal quality standards and regulatory expectations.
  • Work with Quality Assurance, Quality Control, Engineering, Technical Services, Regulatory Affairs, Supply Chain and EHS on operational alignment and inspection readiness.
  • Monitor performance through production KPIs, batch performance, deviations, yield, cycle times, cost, capacity utilization and continuous improvement.
  • Lead and develop supervisors and cross-functional teams.
  • Oversee technology transfer, scale-up, process optimization and validation activities.
  • Promote a strong safety culture and support audits, regulatory inspections, customer visits and remediation plans.
  • Take part in selecting API production personnel with the HR department.

Required profile

  • Bachelor's degree in Chemical Engineering, Chemistry, Pharmacy or a related field; postgraduate studies are an asset.
  • 10-15 years of experience in a senior API production leadership role, with exposure to sterile dry injections and GMP manufacturing.
  • Proven experience leading production teams and developing managers.
  • Availability to work in Tripoli, Greece.

Required skills

  • API manufacturing, production planning, batch records, deviations, CAPAs, change controls and validation.
  • ICH Q7 and international GMP standards.
  • Technology transfer, scale-up and process improvement.
  • Excellent written and spoken English.

What we offer

  • Competitive salary and benefits.
  • Continuous specialized training and career development.
  • A friendly working environment.

Questions fréquentes

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Source : ats:workable

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Published 1 day ago

Expires 1 month from now

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Demo S.A.

Tripoli