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Fill & Finish Manager

3 giorni fa

Latina, Lazio, Italia HAUPT PHARMA A tempo pieno

for the site Borgo San Michele LT, Italy

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.

Your key responsibilities

  • Support the implementation and qualification of the new department and sterile production line, with a focus on isolator technology.
  • Manage the formulation, filling, and packaging activities for injectable products in a sterile environment.
  • Draft and revise department documentation, including SOPs (Standard Operating Procedures) and operational protocols.
  • Manage process deviations and OOS (Out-of-Specification) results, investigating causes and implementing appropriate CAPA (Corrective and Preventive Actions).
  • Ensure the training and ongoing education of staff on operational procedures and new technologies.
  • Supervise and coordinate a team of production operators and technicians.
  • Plan and organize work shifts to ensure optimal coverage.
  • Ensure compliance with cGMP (Good Manufacturing Practices) regulations and internal quality standards.
  • Monitor operational and financial KPIs for the department, identifying and implementing corrective actions to optimize efficiency.
  • Collaborate with the Engineering, Quality, and Maintenance departments to resolve issues and improve processes.
  • Manage internal interactions as well as external interactions with Clients, Regulatory Bodies and Suppliers.

Your profile

  • Bachelor's degree in engineering (preferably Chemical, Industrial, or Biomedical), Chemistry, Industrial Chemistry, CTF (Pharmaceutical Chemistry and Technology), or equivalent scientific/technical disciplines.
  • Solid experience (minimum 3-5 years) in supervisory or production management roles within the pharmaceutical or biotechnology sector.
  • Proven direct experience in managing sterile production and "fill and finish" processes for injectable biological products.
  • Direct experience with isolator technology is a preferred requirement.
  • In-depth knowledge of cGMP regulations (including FDA and EMA).
  • Excellent leadership, problem-solving, and communication skills.
  • Fluent in English and Italian, written and spoken

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation

If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you: Chiara.-

Online seit:

  • Beschäftigungsverhältnis

    Vollzeit
  • Unternehmen

    Haupt Pharma Latina S.r.l.
  • Bereich

    Produktion

Kontakt

Haupt Pharma Latina S.r.l.
• Member of the Aenova Group
• Strada Statale 156 dei Monti Lepini
• 04100 Borgo San Michele LT' Italy