Sterility Quality Assurance Officer M/F

About the position:

Join Excelya, where Boldness, Kindness, and Energy are at the heart of how we work. We believe in innovative solutions and an inclusive environment where collaboration and professional development go hand in hand.

As part of strengthening Sterility Quality Assurance activities at a pharmaceutical site specializing in the manufacturing of sterile injectable drugs, we are looking for a Sterility Quality Assurance Officer to support contamination control and regulatory compliance activities.

Integrated into the Sterility Quality Assurance team and reporting to the Sterility QA Manager, you will contribute to maintaining the validation status of sterile processes and environments, while participating in regulatory inspection readiness activities.

Main Missions:

• Draft and update documentation related to sterility assurance;
• Participate in risk assessment and control activities related to microbiological contamination;
• Perform and update risk analyses associated with sterile processes, equipment, and environments;
• Ensure the follow-up of action plans related to contamination control activities;
• Participate in inspection readiness and regulatory inspection preparation activities;
• Contribute to the continuous improvement of quality practices and systems related to sterile products;
• Collaborate with Quality, Production, Validation, and Support teams to ensure compliance with applicable regulatory requirements;
• Ensure documentary traceability and follow-up of quality actions.

Requirements

About you

At Excelya, we encourage everyone to be bold and develop their potential. We are looking for professionals who share our values and wish to grow in a stimulating environment.

• Experience: You have 3 to 5 years of experience in the pharmaceutical industry, with initial experience gained in a sterile and/or injectable product manufacturing environment.
• Skills: You possess good writing skills and initial experience in quality document management, risk analysis, and sterility-related activities.
• Technical Knowledge: Good understanding of contamination control principles, sterile manufacturing processes, and sterility assurance requirements.
• Regulatory Knowledge: Good knowledge of GMP, Annex 1 of European GMP, and ideally ISO 14644 standard.
• Education: Science degree at Master's level (5 years of higher education) (Pharmacy, Biology, Microbiology, Biotechnology, Process Engineering, or equivalent).
• Personal Qualities: Rigor, analytical skills, synthesis ability, autonomy, open-mindedness, and initiative.
• Languages: Fluent French required. A professional level of English is an asset.

Benefits

Why join us?

At Excelya, we combine a passion for science with teamwork to redefine excellence in the healthcare sector.

What sets us apart:

We are an ambitious health company with over 900 employees across Europe, aiming to become the leading European mid-sized CRO while offering the best employee experience.

Our integrated service model, combining consulting, Functional Service Provider, and Full Service, will allow you to work on diverse and high-value-added projects. You will collaborate with recognized experts and actively contribute to improving the patient journey.

Excel with kindness

At Excelya, kindness is at the core of our actions. We promote equal opportunities and build a diverse, equitable, and inclusive work environment where everyone can thrive, be recognized, and contribute fully to a common mission.

Your challenges become our collective mission. Together, we transform ambitious ideas into concrete achievements, the Excelya way.

Join us today and become an Excelyate!

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