Pfizer Affiliate Quality Operations Associate in Brussels, La Plaine, Belgium

Department Marketing Statement

The Affiliate Quality Operations (AQO) BeLux is responsible to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.

As described in the Product Quality System, AQO is responsible to perform tasks such as release verification; handling of product (quality) complaints; organizing, coordinating and reviewing repackaging/relabeling operations, handle product returns and participate in product quality investigations. AQO will therefore interact with internal stake holders such as Global Supply Chain & Portfolio Management (GSC&PM), Order Desk (OD), Regulatory Affairs (RA) and external stakeholders such as wholesalers, pharmacists, physicians if required.

AQO operates within a dynamic commercial environment and has to be able to shift gears/topics quickly without losing track of long term commitments. Priorities need to be managed from a compliance point of view with regards to timelines, as well as with regards to urgencies.

Job Focus

The key role of the Affiliate Quality Operations (AQO) Associate is to support the AQO team in Belgium with the establishment and maintenance of an appropriate and sustainable Quality Management System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.

In addition, the AQO Associate will in co-operation with the AQO lead assist with the investigation and resolution of all product quality issues discovered or originating in the PCO BeLux and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and PGS or GES on such issues.

The AQO Associate in Belgium and Luxembourg is the back-up Qualified Person (QP) for batch release following relabeling/repackaging operations (GMP responsibility) for legal entities Pfizer NV/SA and Pfizer PFE Belgium bvba/sprl.

Responsibilities

I. Product Quality System

• Support the AQO Lead with the deployment and the maintenance of an effective and sustainable management of the Quality System.

• Support the AQO Lead in the deployment and training of all applicable Product Quality SOPs (issued by AQO) within the PCO.

• Support the AQO Lead in the supervision of processes related to GDP (drug supply, stock management, stock availability, customer management, logistics complaint handling, T° monitoring and transport of products, product disposal...).

II. Deviation Management (in conjunction with the PGS Quality Operations)

• Support the AQO Lead in the investigation of deviations from Product Quality and Compliance requirements that occur within the responsibility of the country organization and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.

III. Product Complaint Handling

• Signs-off responses to complainants developed and issued in a timely manner.

• Reviews the product complaint form before sign-off for closure by the AQO Lead.

IV. Notification to Management

• in absence or by delegation of the AQO Lead Informs PGS QO Management of significant deviations and complaints.

V. Inspections and Internal Audit

• Support the AQO Lead in the preparation and coordination of Regulatory Agency and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities at the PCO.

• Support the AQO Lead with the implementation of the identified actions within agreed timeframes.

VI. Local Contractor Quality Oversight

• Oversees quality operations at contractors, which includes but is not limited to:

o Contractor Assessment and Approval: ensures all GMP/GDP contractors have been formally assessed and approved.

o Deviation Management: evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. If necessary, initiates the "Notification to Management" process.

o Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM).

o Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.

• Facilitates, together with the AQO Lead, the Pfizer Manufacturing Supplier Quality Assessment (MSQA) audit process at the contractor. Helps to define appropriate action plans for improvement and follow-up and communicate action closures.

VII. Oversight of local Repackaging and Relabeling Operations

• Ensures relabeler/repackager has been assessed and approved.

• Reviews documentation related to the repackaging/relabeling operation.

VIII. Development and Maintenance of Consistent Quality Culture

• Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.

IX. Local BU support

• Quality support for "Tender" filing at community level as well as at hospital level.

Qualifications

SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE

Minimum level of education:

• Master in Pharmaceutical Sciences

• Qualified Person certification in progress, aspiration to complete or completed according to the Royal Decree of 14 December 2006 article 84 and recognized by the Belgian Agency.

Experience:

• Minimum 1-5 years of experience working in Pharmaceutical and related industries in a

Quality Operations, Manufacturing or Regulatory role.

• Previous working experience in GDP is preferable

Technical/Functional/Professional Competencies Specific to the job:

• Assesses risk and make's sound and effective quality decisions under pressure through analysis of data.

• Diplomatic in communication with internal and external customers.

• Show strong negotiation and effective communication skills. Is influential.

• Self-motivated individual.

• Able to work effectively in cross-functional teams & collaborate.

• Builds trust and credibility with internal and external business partners and Regulatory Authorities.

• Moves from an overall picture view to details and returns again, as situations develop and needs change (helicopter view and ability to prioritise).

• Computer literate.

Languages:

English verbal and written

French or Dutch verbal and written with motivation to learn the other language

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