Overview:
We are looking for a QA Associate with solid experience in Sterile Manufacturing to join our Quality Assurance GMP Compliance team. The successful candidate will play a critical role in managing deviations system, conducting thorough investigations, primarily focusing on those related to dclassified areas (Cleanrooms) and microbiological and particulate contamination events. She/he will also ensure compliance with strict GMP requirements, with a particular focus on EU GMP Annex 1 and company standards.
Main Activities & Responsibilities:
Deviation and Contamination Investigations: Manage a wide variety of quality and manufacturing deviations. The core focus will be on directing investigations related to out-of-limit Environmental Monitoring (particulate and microbiological), non-conformities in sterility or bioburden tests, and behavioral or gowning deviations in classified areas (Grades A, B, C, D).
Advanced Root Cause Analysis (RCA): Conduct in-depth root cause analyses for events linked to potential asepsis breaches or general process non-conformities, working closely with Production, Microbiology/Quality Control, and Engineering departments.
CAPA Management: Identify, implement, and verify the effectiveness of Corrective and Preventive Actions (CAPAs) to prevent the recurrence of contamination events and other quality discrepancies.
GMP and Annex 1 Compliance: Ensure the alignment of all manufacturing and control procedures for injectable drugs with current cGMP regulations for sterile products).
Document and Procedure Management: Draft and review operating SOPs and working instructions
Training and Quality Culture: Promote and support the training of personnel operating in production departments.
Job Requirements:
Education: Master's Degree in Microbiology, Biology, Biotechnology, Pharmacy, Pharmaceutical Sciences, or related scientific disciplines (a background in microbiology is considered a strong plus).
Experience: At least 3-5 years of experience in Quality Assurance within pharmaceutical companies manufacturing sterile/injectable drugs.
Specific Technical Skills:
In-depth knowledge of aseptic processing, sterilization, and decontamination processes.
Strong command of European cGMP regulations, with excellent knowledge of the new EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).
Proven experience in managing critical deviations and applying Root Cause Analysis techniques to both general process issues and specific microbiological/particulate events.
Languages: Good knowledge of English (both written and spoken)
Soft Skills: Excellent problem-solving abilities, an analytical and risk-based approach (Risk Management) and excellent interpersonal skills to interface with various company departments.
The selected candidate will be employed under Category C in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.
