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Operational Quality Assurance Manager

Operational Quality Assurance Manager

Brussels, 1120, Belgium

 

CatalentPharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

 

For our growing sterile production site located in Brussels (Neder-Over-Heembeek) specializing in sterile technologies, we are currently looking for an Operational Quality Assurance Manager. Producing over 15 million syringes each month for numerous clients and currently expanding its capabilities, our Brussels site is a pillar of Catalent’s sterile production services. The diversity of our clients and products – which are approved by numerous regulatory bodies, including EMA & FDA – accounts for a complex technical environment where people eager to take on challenges can thrive and develop.

 

The Operational Quality Assruance Manager will report directly to the Quality Operations Director. He/She will manage a team of around 10 people on the shop floor and have the chance to mentor junior recruits. This role will allow you to do QA field work with the production teams and enjoy interactions with all other departments as well. What we offer is a the challenge to work in a sterile environment, and an opportunity to further develop your skillset and to grow within an international company but a human-sized site.

 

Responsibilities of the Operational Quality Assurance Manager:

 

  • Ensure daily operations of the QA on the shop floor team, which works in early and late shift, and participate in daily operational meetings with manufacturing, packaging, and our laboratories
  • Create and maintain a good relationship with our Production and QA Release (QPs) teams, with a focus on ensuring Quality rather than controlling it, and foster a successful collaboration that will guarantee the safety of our patients
  • Review and approve critical qualifications needed from shop floor operators (Visual Inspection, gowning, media fill, line clearance) and ensure operators’ continuous education by actively observing operations from a Quality standpoint, performing spot-checks and providing adequate feedback
  • Review and approve master batch records (analytical, manufacturing, packaging)
  • Review batch records, as well as handle events, deviations and complaint investigations
  • Overview  AQL activities for both Visual Inspection and final packaging
  • Participate to media fill activities as Quality observer
  • Participate to customer audits & regulatory inspections
  • Execute self-inspections and Quality spot-checks

 

Skills and experience of the Operational Quality Assurance Manager:

 

  • Scientific background (Pharmacy, Industrial/Civil Engineer, (Bio)Chemistry or equivalent)
  • Extensive experience in the pharmaceutical industry
  • Experience of sterile operations and knowledge of the aseptic area is a must  
  • Experience working in a GMP environment
  • Excellent command of French and English in writing and speaking

 

The ideal candidate should be able to demonstrate excellent communication and organizational skills, high personal integrity and ethics, an acute sense of accountability, strong motivational and team leadership qualities, as well as the ability to solve problems and make decisions that will ensure both patient safety and customer satisfaction.

 

Interested in the Operational Quality Assurance Manager role? Please hit the APPLY button below

 

 

About Catalent

 

CatalentPharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com

                                                    

More products. Better treatments. Reliably supplied.™

                                                                                        

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: 

CatalentPharma 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.

 

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Job Information

  • Company
    Catalent Pharma Solutions
  • Location
    Neder-Over-HeembeekBrussels
  • Job Status/Type
    Full Time Employee
  • Date Posted
    2/20/2017
  • Industries
    Biotechnology/Pharmaceuticals
    Medical Devices and Supplies
    Other/Not Classified
  • Reference Code
    CAT/OPER/AC
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