Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

What will you do?

Analyze technical documentation.Evaluate APS protocols and reports per GMP and corporate standards for manufacturing sterile drug products.Review of manufacturing instructions (MBR) for APS runs.Issue or review technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions.Ensure accurate management and archiving documentation in line with GMP and internal procedures.Coordinate manufacturing activities during APS exercises.Assist in developing and revising APS department SOPs.Ensure all relevant activities are adequately evaluated and managed through change control management.Assist in preparing for and engaging in client and regulatory audits related to APS operations.Maintain high-level client service delivery performance by fostering positive relationships with clients and coordinating activities to ensure timely communication.Provide adequate reporting to Area Management about potential issues.

How will you get here?

Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.At least 2-3 years of experience in the pharma/chemistry industry.

Knowledge, Skills, Abilities:

Proficient in English and Italian.Knowledge of sterility assurance concepts.Knowledge of pharmaceutical legislation and national/international laws.Good communication skills and partnership.Propensity to prepare technical documentation.Attention to details and precision.Organizational skills.