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Validation and Regulatory Quality Assurance

Pfizer


Location:
Bruxelles, Bruxelles 1040
Date:
01/26/2018
2018-01-262018-02-26
Pfizer
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Job Details

**ROLE DESCRIPTION**







The Pfizer site located in Puurs (Antwerp) is among the world's largest aseptic drug manufacturing sites and is part of Pfizer's biotech manufacturing network.



The site has a strong base of established drug products such as sterile antibiotics, prostaglandins and corticosteroids for global distribution, as well as innovative drugs and vaccines. It is also Pfizer's standard launch site for new biotechnological drugs that have shown promising results in clinical trials.



The Pfizer Puurs Regulatory and Validation Department located in Puurs (Antwerp) is seeking a dynamic **Validation and Regulatory Quality Associate** to join our team to support the commercial launch of new (biological) drugs.







In this role you will be responsible for validation and new product registration activities of the assigned products. You will work in cross-functional teams with different Puurs departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site.



Are you seeking to work with innovative products, in an exciting and fast evolving environment? Join our team!







**MAIN RESPONSIBILITIES**







You ensure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations (GMP, ICH, ..) and with the description in the submitted registration dossiers.



To accomplish the above:







+ You perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations. In this quality authority role you will work closely together with different project teams and different departments within Pfizer Puurs as well as with R&D.



+ You support regulatory submission of the new products by informing site colleagues of regulatory requirements and by providing the project details and the supporting validation data to GCMC. In this regulatory role you work closely together with global regulatory Pfizer colleagues and R&D.



+ You coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.







**EDUCATION, TRAINING AND/OR EXPERIENCE**







+ Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)



+ Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience or interest in validation, regulatory and quality.



+ Specific skills:



+ Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation



+ Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset.



+ Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.



+ Insight and understanding of shareholders needs and requirements.



+ Dynamic, flexible, enthusiastic and eager to learn



+ Takes initiative and ownership to deliver on time without compromising on quality



+ Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation)



+ Fluent in written and spoken English and Dutch







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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