Pfizer QO Engineer in Puurs, Belgium
This position is accountable for release of products produced by a Third Party Manufacturer, to the market, in accordance with Company and legal requirements (PQS, GMP etc).
In addition, this position will be responsible for the quality system Outsourced activities and make proposals for continuous improvement of products and processes. This position is the primary contact for market queries concerning Outsourced Activities.
This position reports to the QA team leader within the Market Release team. The position will also be accountable for backup of QA team leader during his/her absence.
Assure introduction of new purchased products and outsourced activities and work closely with Manufacturing Operations and supporting departments.
Assure that products manufactured and packaged by and for Third Party Manufacturers meet Company and legal requirements.
Assure that products purchased and used in the Puurs plant meet Company and legal requirements.
Review batch related manufacturing documentation of outsourced activities for conformity.
Design test plans for purchased product batches.
Assure continuous improvement of batch release process of contract manufacturing products
Primary contact for all external queries of markets, affiliates, contractor sites related to outsourced activities in the company
Responsible for operating and maintaining the Quality Assurance system for outsourced activities
Investigate batches not meeting specifications and prepare recommendations to the release engineer
EDUCATION AND EXPERIENCE
Master degree in a scientific discipline, preferably in Pharmacy
Preferably experience in a manufacturing environment
Experience with release of biological products or vaccines is an advantage
Good communication skills: communication, negotiation and networking skills (in Dutch & English)
Excellent documentation skills (technical report writing in Dutch/English)
Good time management and prioritizations skills
Ability to build relationship with internal and external customers/partners (interact empathy, clarity and assertiveness)
Strong leadership and coaching skills
Ability to work in synergy with all departments
Mindset of continuous improvement
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.