Catalent Pharma Solutions QA Support Expert in Brussels, Belgium

Job Description

We are currently looking for a Quality Assurance Support Expert for our Sterile Development and Production site located in Brussels (Neder-Over-Heembeek)

Position Summary

Our QA Expert will report to the QA Support Manager and will be part of the field QA team.

The Role

  • Review and approve master batch records

  • Review of executed master batch records (manufacturing, packaging)

  • Participate in complaint investigations,

  • Ensure management of deviations: review NOE, deviations and co-ordinate investigations.

  • Participate actively in investigations together with production, technical services, QC…

  • Review and FU of critical qualifications of production operators (gowning, VI, line clearance, mediafill…)

  • Quality participation in mediafill

  • Provide QA support to new product introduction projects and related validation activities

  • Maintain an appropriate level of compliance to Catalent QMS; review changes to QMS and assess impact to site and drive ‘in place’ and ‘in use’.

  • Provide support during customer audits and regulatory inspections

The Candidate

  • Scientific university degree (Pharmacist, Engineer or equivalent)

  • At least 5 years of experience in a pharmaceutical/Bio/Medical device environment in a quality role

  • Experience in working in a GMP and sterile environment

  • Very good knowledge of English and French in writing and speaking

  • Good understanding of manufacturing and packaging processes

  • Demonstrable knowledge of commissioning and qualification and validation requirements is a plus

  • Demonstrable experience in Deviation handling - review and approval, root cause analysis, potential product analysis

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits :

  • What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile business

  • Potential for personal development within an international company

  • Defined career path and annual performance review and feedback process

  • Contributory pension and benefits package all offered from day one of employment

  • 36 days’ holiday + bank holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.