Sterility Assurance Lead – Microbiology & Compliance

Aenova Group; Latina; Vor Ort; EUR 30.000 - 40.000; Vollzeit

Zusammenfassung

Haupt Pharma Latina S.r.l. in Latina, Italy, is seeking an experienced professional to support Sterility Assurance and aseptic processing within sterile manufacturing.

You will collaborate across Production, Engineering, MS&T, Validation and QA to minimize microbiological risks. The role requires a scientific degree and at least 3 years in Sterility Assurance, Microbiology or Quality in a sterile pharmaceutical environment, with strong GMP knowledge and English skills.

Qualifikationen

• University degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields); Master’s degree preferred.
• At least 3 years of relevant experience in Sterility Assurance, Microbiology, Quality or Manufacturing within a sterile pharmaceutical environment.
• Good knowledge of GMP and EU GMP Annex 1; knowledge of FDA requirements is considered an advantage.
• Experience or solid knowledge of aseptic processing, APS and contamination control principles.
• Knowledge of Contamination Control Strategy principles.
• Good written and spoken English.
• Strong analytical, communication and cross-functional collaboration skills.
• Experience with cleanroom qualification, technology transfer, environmental monitoring and electronic quality systems is considered a plus.

Aufgaben

• Support and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.
• Collaborate with Production, Engineering & Maintenance, MS&T, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.
• Support the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.
• Support deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.
• Support the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).
• Provide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.
• Support technology transfer, qualification/validation and continuous improvement projects within sterile manufacturing.

Kenntnisse

GMP knowledge

Aseptic processing

Analytical skills

Cross-functional collaboration

English proficiency

Ausbildung

University degree in a scientific discipline

Tools

Environmental monitoring

Jobbeschreibung

Haupt Pharma Latina S.r.l. in Latina, Italy, is seeking an experienced professional to support Sterility Assurance and aseptic processing within sterile manufacturing.

You will collaborate across Production, Engineering, MS&T, Validation and QA to minimize microbiological risks. The role requires a scientific degree and at least 3 years in Sterility Assurance, Microbiology or Quality in a sterile pharmaceutical environment, with strong GMP knowledge and English skills.