Quality Assurance Project Specialist

Join Excelya, where Audacity, Kindness, and Energy are at the heart of our way of working. We foster a collaborative environment in which everyone can develop their expertise and contribute to high-value-added projects in the Life Sciences sector.

As part of strategic projects within a pharmaceutical environment, we are looking for a Project Quality Assurance Engineer – Qualification & Validation to support incoming product transfer projects in dry forms and packaging.

Integrated into the Qualification, Validation & Projects Quality Assurance department, you will be the Quality Assurance representative within project teams. You will be involved in all Quality activities associated with projects, from defining the qualification strategy to executing qualifications and monitoring the quality system.

Your missions:

• Represent Quality Assurance within project teams and ensure the application of qualification policies for new equipment.
• Define and draft project-associated Quality documentation, including user requirements, specifications, validation master plans, and associated reports.
• Manage the quality system at the project level: Change Controls, CAPA, deviations, and document management.
• Perform criticality analyses and risk analyses related to the implemented equipment and systems.
• Draft and review qualification documentation: FAT, SAT, IQ, OQ, PQ, and PV, according to project needs.
• Participate in on-site qualification execution, in close collaboration with User and Engineering teams.
• Review and contribute to the drafting of procedures, operating methods, and other Quality documents necessary for operational startup.
• Participate in project follow-up meetings and ensure Quality Assurance representation to the various stakeholders.
• Ensure compliance with qualification timelines and monitor Quality activities associated with projects.
• Contribute to the necessary regulatory processes within the framework of modifications made to facilities.

Requirements

At Excelya, we are primarily looking for meticulous, autonomous professionals capable of collaborating effectively with multidisciplinary teams.

• Experience: You have significant experience in Quality Assurance and Qualification/Validation in the pharmaceutical industry.
• Process Expertise: You ideally have experience in dry form processes, particularly in extrusion, LAF granulation, compression, and/or packaging.
• Qualification/Validation: You are proficient in equipment qualification activities as well as the drafting and execution of associated protocols and reports.
• Quality: You are comfortable with the management of Change Controls, CAPA, deviations, risk analyses, and GMP documentation.
• Regulatory: You have a good knowledge of European and FDA GMP, Annex 15 of EU GMP, 21 CFR Part 11, GAMP 5 principles, ICH Q9, and ALCOA+.
• Education: Engineering degree, Pharmacy degree, or equivalent scientific/technical level.
• Personal Qualities: Rigor, autonomy, organization, writing and synthesis skills, interpersonal skills, and ability to work in a project team.
• Languages: Professional English minimum B2 level, enabling you to draft GMP documentation in English and participate in meetings or exchanges with international contacts.

Benefits

Why join us?

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

What sets us apart:

We are an ambitious healthcare company that offers its employees the opportunity to grow on diverse and high-value-added projects. Our integrated service model, combining consulting, Functional Service Provider, and Full Service, allows our employees to develop their expertise alongside major players in the Life Sciences.

By joining this mission, you will directly participate in pharmaceutical product transfer projects, with a central role in quality control, equipment qualification, and preparing facilities for operation.

Excellence with kindness

At Excelya, kindness is at the heart 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, in the Excelya way.

Apply today and become an Excelyate!

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