Senior Qualification Specialist - Pharmaceutical Manufacturing H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

As a Gidy Expert Qualification at Excelya, you will be at the forefront of ensuring compliance and qualification for innovative solutions within the biopharmaceutical landscape. This unique role involves a deep understanding of regulatory standards and the application of best practices in qualification processes.

You will work closely with our teams to design, implement, and optimize qualification protocols that align with our clients' needs and maintain the highest quality and safety standards in their processes.

Main Responsibilities:

- Define the Qualification/Validation strategy.
- Perform risk analyses to determine the required qualification/validation tests.
- Prepare and review qualification/validation documentation: validation plans, rationales, protocols, and reports.
- Review, challenge, and comment on supplier documentation.
- Plan and coordinate activities with relevant departments (Production, Laboratory, Contractors, Project Managers).
- Organize and supervise validation tests, ensuring objectives, methodology, acceptance criteria, and expected results are met.
- Review results, report anomalies, assess impact, and propose or implement corrective actions.
- Ensure compliant documentation according to regulatory requirements and internal procedures.
- Collect necessary information and documents to prepare qualification dossiers.
- Comply with HSE rules.

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here'swhatmakesusunique:

Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.

Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.

About You

To excel in this pivotal role, you should have a solid background in biopharmaceutical operations and compliance, along with a proactive approach to problem-solving and quality assurance.

- Experience: Extensive experience in qualification and validation within biopharmaceutical or healthcare settings. Proven track record of managing qualification processes for complex systems.
- Skills: Strong analytical and documentation skills; knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems. Excellent leadership and communication abilities.
- Education: Bachelor's degree in a relevant scientific or engineering field; Master's degree preferred.
- Languages: Proficient in English; knowledge of additional languages is a plus.

Join us at Excelya, where your expertise in Gidy qualifications will drive innovation and success in the biopharmaceutical industry!