Pfizer Responsible Person in Capelle Ad Ijssel, Netherlands
The incumbent will work with Logistics Centre (LC) Quality teams, EU Release Sites (MAHs) within SCMQO and key stakeholders including quality teams at Pfizer Country Offices, PGS manufacturing sites, Customer Services, Customs and applicable business support functions to ensure that all Pfizer products supplied to distributors meet all regulatory requirements, maintain product quality, safety and security requirements according to global BoH expectations.
This role provides Quality Oversight of Pfizer Export B.V. activities relating to the supply of product to customers globally. The role will ensure that any delegated activities are suitable managed through appropriate agreements and where necessary using validated systems and processes.
The role has accountability for oversight of the design, implementation, execution, monitoring and compliance of Quality Systems related to product supply under the wholesale license.
Principal Duties & Responsibilities
Function as the lead Responsible Person (RP) for Pfizer Export B.V. wholesale locations. Ensure timely and adequate RP communication and cover with other deputy RPs.
The main responsibility of the RP, among others, is focusing on compliance of products and services with the legal requirements, regulatory commitments, company's policies, customer expectations and business needs.
The RP's responsibilities, among others, include:
Ensuring that a quality management system is implemented and maintained;
Focusing on the management of authorised activities and the accuracy and quality of records;
Ensuring that initial and continuous training programmes are implemented and maintained;
Coordinating and promptly performing any recall operations for medicinal products;
Ensuring that relevant customer complaints are dealt with effectively;
Ensuring that suppliers and customers are approved;
Approving any subcontracted activities which may impact on GDP;
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
Keeping appropriate records of any delegated duties;
Deciding on the final disposition of returned, rejected, recalled or falsified products;
Approving any returns to saleable stock;
The role will involve participation in SCMQO projects based on business needs and representing SCMQO during PEBV meetings, such as team meetings, advisory panel and any other projects.
Educational Qualification & Experience Required
A minimum of a Bachelor degree in Sciences or Engineering
Minimum of 5 years professional experience in the pharmaceutical industry or related branches in the area of Quality Operations, which was at least partially acquired in Netherlands, preferably in the GDP area or in production.
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.
Fluent in Dutch and English (spoken and written), ability to speak and read other European languages will be an added advantage.
Have adequate experience in Quality Assurance and the technical knowledge to meet the requirements.
Assess risks and make informed and effective decisions, even under pressure, by evaluating all available data.
Diplomatic in communication with internal and external customers.
Self-motivated personality who appreciates being able to work independently.
Ability to work in cross-functional teams and to take the lead
Establishes trust and credibility with internal and external partners and the Authority.
Has the ability to move from the big picture to the detailed level as needed, and is able to make quick decisions, escalate and communicate with the urgency required (change perspective, set priorities)
Experienced in the use of common computer programs
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required of personnel so classified.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.