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QA Release Officer & QP Back-up

QA Release Officer & QP Back-up

Brussels, 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 a QA Release Officer & QP Back-up. 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.

 

Our QA Release Officer & QP Back-Up will take part in the release activities of the Brussels site. AS QP Back-Up, you will carry out the duties of a Qualified Person as described in Eudralex, Chapter 4, annex 16, in the absence of the Site Responsible Pharmacist. What we offer is an exciting role, a chance to grow and learn new skills in a global company but a human-sized site, and in the most challenging quality environment within the pharma industry – the sterile injectable production.

 

Responsibilities of the QA Release Officer & QP Back-up:

 

  • Release pharmaceutical products according to GMP and Quality Agreements
  • Review and approve documents related to batch release (master batch records, deviation reports, derogations and complaints, change controls, environmental control forms, testing instructions, raw material identification documents, etc.)
  • Review and approve validation and qualification documents
  • Approve procedures related to product manufacturing
  • Review and investigate complaints and major/critical deviations as QA expert
  • Be the single point of contact for our clients regarding QA matters, and ensure contact with Belgian authorities
  • Take part in audits, Quality projects, Annual Product Quality Reviews and Quality Spotchecks on the shop floor.

 

Skills and experience of the QA Release Officer & QP Back-up:

 

  • Pharmacist with Belgian QP number is a must
  • Relevant experience in a batch release team within the pharmaceutical industry
  • A first experience as Qualified Person is a strong asset
  • Experience in working in a GMP environment
  • Fluency in English and French
  • Day job, but ready to work in shifts (06:00-14:00/14:00-22:00/22:00-06:00) occasionally to support production needs

 

The ideal candidate should be able to demonstrate excellent communication skills, high personal integrity and ethics, and an acute sense of accountability. He/she should be someone able to show the necessary rigour and proactivity to ensure both patient safety and customer satisfaction.

 

**If interested in the QA Release Officer & QP Back-uprole please apply 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
    3/17/2017
  • Industries
    Biotechnology/Pharmaceuticals
    Medical Devices and Supplies
    Other/Not Classified
  • Reference Code
    0019394
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