The role of QO Engineer External Affairs is situated within the QA organization which is responsible for Quality Assurance and release of vaccines at the Pfizer site in Puurs.
As QO Engineer External Affairs you are the primary contact for any activity related to the Official Control Authority Batch Release of vaccines by the OMCL.
You are accountable for releasing vaccines to the market in accordance with the OCABR / WHO requirements. You will be working in a dynamic and growing environment and will actively collaborate with both internal and external parties.
You will be supporting both routine, operational activities as project related activities for an intercompany transferring vaccine product.
You report to the QA Lead / QA Manager in a vaccines oriented organization.
Job Responsibilities : General
Partner closely with customers and stake-holders (both internal and external) to understand and deliver on commitments.
Responsible for day to day activities related to the OMCL release of the vaccine batches.
Use visual management to track and trend activities.
Represent QA at product, technical and regulatory meetings and co-ordinate all support activities associated to OMCL release.
Liaise between the OMCL and all involved parties both internal (QC, Site Compliance, QA, Supply) and external (COQA for Contract Manufacturer, GCMC, Pfizer Drug Substance sites) connect technical experts and sites for new vaccines product to build technical expertise within the site.
Regularly report out to management on achievements and challenges.
Drive process efficiencies and tracking to contribute to timely supply of products.
You can be requested to participate in assignments as defined by the QA Lead / QA Manager.
Job Responsibilities : Specifics
Fine-tune the routine release process for the Nimenrix vaccine manufactured by Contract Manufacturer.
Set-up the OMCL release process according to the OCABR / WHO guidelines for the Nimenrix vaccine manufactured by Pfizer Puurs as part of the intercompany transfer project (including release tracking system and documentation / procedures set-up).
Propose the organization structure in order to perform routine activities related to the OMCL release.
Manage direct communications with a regulatory body primary liaison with the EU Official Medicines Control Laboratory (OMCL).
Manage the compilation of Board Of Health protocols for Nimenrix manufactured by both Contract Manufacturers and Pfizer Puurs.
Development of Board of Health protocols to support new market launches (e.g. Official Release by CBER (US)).
Liaise with Network and Pfizer Puurs Supply Chain to ensure Nimenrix vaccine releases available to meet the market demand.
In collaboration with QC & Site Compliance, support and guide the communications with country specific officers in liaison of National Control Laboratories (outside EU).
Weekly meeting with Network supply chain and COQA.
Work closely with COQA colleagues for Contract Manufacturer to ensure market release requirements are met.
Point of contact for OMCL representatives to ensure timely testing and release of products.
Co-ordinate all variation changes that impact the BOH protocol and notify the OMCL of these changes in liaison with GCMC.
Co-ordinate (bi-)annual F2F and ad hoc meetings with the OMCL.
Manage the OMCL batch allocation (including yearly schedule set-up).
Generate monthly metrics for OMCL Release of the Nimenrix vaccine for network planning.
Support the activities in the OMCL selection process for new vaccines in the pipeline.
University degree in a scientific discipline (Biochemistry, Pharmacy).
QC / laboratory knowledge (i.e. analytical methods like bio-assays) is an asset.
Knowledge of vaccines Drug Substance & Drug Product manufacturing is an advantage.
You have excellent public relations & communication skills, both oral and written (Dutch / English).
You have good documentation skills (writing in Dutch / English).
You have good project management skills (cost, time, scope); handling conflicting priorities.
You can work autonomously but are also very collaborative with both internal and external parties.
You are diplomatic but surely convincing within an assertive attitude.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.