Pfizer Release Engineer Utilities in Puurs, Belgium
This position is accountable for releasing product in accordance with Company and legal requirements (PQS, GMP etc).
In addition, this position will perform and document all necessary investigations to support assessment of the product being acceptable and make proposals for continuous improvement of processes. This position is the primary contact for the Utilities department in case of quality deviations.
This position reports to the QA Lead within the Quality product team.
In this role you will be, together with a colleague, the primary contact for the Utilities department in case of quality deviations; the Utilities department is responsible for black utilities, clean utilities, electricity and HVAC.
Evaluate incidents that occur in the Utilities department and prepare recommendations to the QA Manager/QA lead.
Evaluate root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
Assure that products manufactured and packaged in Puurs meet Company and legal requirements.
Investigate batches (water batches) not meeting specifications and prepare recommendations to the QA Manager/QA lead.
Coordinate cross functional investigations in case of complex root causes and work closely with Manufacturing Operations and supporting departments.
Operate and maintain the Quality Assurance systems.
Approve master documents and SOP's.
Prepare Quality Performance Review.
Support continuous improvement of utilities processes through:
Quality deviation investigation (events/QAR's)
Trending of LIRs (Lab investigation reports), events and QARs (Quality Assurance Reports)
Participation in operations, system teams and daily operations review meetings
Contribute to timely supply of products.
This position can be requested to participate in assignments as defined by the QA Manager /QA lead.
University degree in a scientific discipline, preferably in Pharmacy, Engineering (e.g. Civil, Bio)
Preferably experience in a manufacturing environment with a strong interest in utilities systems (black utilities, clean utilities, electricity, HVAC).
Experience with quality investigations is an advantage.
Good communication skills, verbal and in written, in Dutch & English
Excellent documentation skills (technical report writing in Dutch/English)
Good time management and prioritizations skills
Human interactions (diplomacy, convincing, assertiveness,...)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.