Pfizer is a research-based, global biopharmaceutical company. We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.
The main responsibility of the Responsible Person of Upjohn Legal Entity will be to work with the PSC (Pfizer Service Company) team and key stakeholders including Customer Service Operations, IICC (Inbound, Inventory, Compliance, Controlled Substances), Customs and ICMD (Intercompany Master Data) to ensure that all products physically and / or financially owned by Upjohn are released for sale to global markets in accordance with the EU GDPs.
The role has accountability for the implementation, execution, monitoring and compliance of the Quality Systems in support of the release for sale activities.
This person act as an RP of behalf of Upjohn.Operational Quality Review, evaluate and support complex investigations and present formal notifications of significant issues to senior management and Quality Review TeamsEnsure fulfillment of local legal regulationsEnsure that the provisions of the licence are observedEnsure that the operations do not compromise the quality of medicinesEnsure monthly metrics are gathered and communicated in a timely wayAct as RP for Upjohn for the GDP licenses responsible for as notified to the respective BoH.
The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include : Ensuring that a quality management system is implemented and maintainedFocusing on the management of authorised activities and the accuracy and quality of recordsEnsuring that initial and continuous training programmes are implemented and maintainedCoordinating and promptly performing any recall operations for medicinal productsEnsuring that relevant customer complaints are dealt with effectively if applicableEnsuring that suppliers and customers are approvedApproving any subcontracted activities which may impact on GDPEnsuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in placeKeeping appropriate records of any delegated dutiesDeciding on the final disposition of returned, rejected, recalled or falsified productsApproving any returns to saleable stockEnsuring that any additional requirements imposed on certain products by national law are adhered toBasic QualificationsA minimum of a Bachelor degree in Sciences or EngineeringA RP / QP qualification recognized by Belgian Health AuthoritiesA minimum of 10 years previous experience is required within the pharmaceutical industry preferably within the Quality and / or Compliance fields.
In depth knowledge of GDP and legal requirements.Able to work well in a matrix organization set up and influence key stakeholders.
Good interaction and clear communication skills with multiple stakeholders is required.Worked extensively with contractors and service providers is an asset.
Able to influence indirect reports to deliver results.Fluent in English (spoken and written), ability to speak and read Dutch or French will be an added advantage.
Experience in Quality administered systems.Excellent system skills Word and Excel essential, experience with electronic documentation control systems advantageousPrevious use of Trackwise® and SAP beneficial.
Preferred QualificationsScientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation.
Knowledge of drug regulations and regulatory guidance of FAMHP and other 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.Able to demonstrate good planning and organisation skills.Ability to apply technical knowledge and understanding to making appropriate and timely risk based decisions.
High level of self- integrity and ethical conductExcellent Quality Decision making skills.We Offer Temporary position for 12 months, with the possibility to extend it to permanent.
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
We offer you a challenging job in an international and complex environment within a dynamic team. For all our projects regarding diversity and inclusion on the work floor, Pfizer is closely collaborating with Actiris.
LI-PFEPfizer 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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