Quality Assurance Specialist

Conteúdo do emprego

Are you a QA Specialist? Do you like working in the (bio)pharmaceutical industry? Are you looking for a new challenge? Say no more. We got the perfect job for you!

Rousselot is looking for a QA SPECIALIST BIOMEDICAL for their department in Gent.

Are you interested or do you want more information? Feel free to contact me by mail at: younnes.ibrahimi@rss.randstad.be or by phone at: +32 2 472 78 22.

All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age or disability, are strongly encouraged to apply. Your application will be handled discreetly!

Company:

Rousselot is the world’s leading producer of gelatin & collagen and is a recognized partner of pharmaceutical, food and technical industries.

Rousselot is seeking to fill the position of Quality Assurance Specialist Biomedical. The Quality Assurance Specialist Biomedical is, together with the Quality and Compliance Lead Biomedical, responsible to ensure that products withing the Biomedical segment are manufactured (internally or externally), stored, packaged, released, labeled, distributed in accordance with Good Manufacturing Practices (cGMPs).

Your main responsibilities will be

• Batch disposition and preparing certificate-of-analyses: disposition of finished product batches, including review of batch documentation.
• Incoming release of raw materials, packaging, consumables
• Ensure on time resolution of non-conformances and OOS results.
• Assist in and/or lead various investigations as needed (customer complaints, supplier complaints, internal deviations, …)
• Assist in review and approval of change control proposals.
• Qualify and evaluate suppliers (raw material, consumables, packaging, services). Perform supplier audits to assure processes used/data generated meet all quality standards. Define and update quality agreements with suppliers, clearly defining the quality requirements. Guarantee the follow-up of the defined CAPA’s.
• Update product and supplier specifications where needed
• Check and make sure traceability documentation is complete and correct
• Keep SOP’s and work instructions of the processes owned by the quality department up-to-date
• Assist in employee training and make sure the training schedule is up-to-date and followed
• Member of internal audit team: perform internal audits to verify the compliance of the Biomedical Quality Management System. Guarantee the follow-up of the defined CAPA’s.
• Provide support on customer audits and/or authorities and follow-up of the deviations & action points in timely manner.

What do we expect from you?

• A relevant Master’s degree or equivalent through experience
• Min. 2 years of experience in a cGMP (bio)pharmaceutical environment
• Experience with document control systems
• Excellent knowledge of English and Dutch. French is an asset.
• Strong problem solving, issue resolution, root cause analysis, planning and organization skills

What do we have to offer?

You will contribute to the development of the QA department and will be greatly rewarded for your efforts.

• Permanent contract
• Attention to worklife balance
• Competitive salary package
• Year-end bonus
• Vacation pay
• Medical insurance
• Pension plan
• Eco vouchers
• Meal vouchers
• Above-average number of leave days
• A culture of respect, entrepreneurship and innovation
• A job with a great social importance

Contact:

Are you interested or do you want more information? Feel free to contact me by mail at: younnes.ibrahimi@rss.randstad.be or by phone at: +32 2 472 78 22.

Your application will be handled discreetly!