Quality Specialist Operations Csp - Puurs, België - Pfizer
Beschrijving
ACCOUNTABILITY OBJECTIVE_
This position is accountable to perform and document all necessary investigations to support assessment of the product being acceptable (either locally produced or by a Third Party Manufacturer) and make proposals for continuous improvement of products and processes.
This position is the primary contact for everything related to the packaging process, as well as Third Party Manufacturer in case of quality deviations.
This position reports to the QA Lead (CSP) Release Operations.- PRINCIPAL ACCOUNTABILITIES_
- Release products (finished and purchased semifinished products) in accordance with GMP, MDCP and regulatory requirement (if the applicant holds a QP certificate). This is ensured through appropriate release and stability testing and evaluation of test results.
- Evaluate incidents that occur in their respective facility and prepare recommendations to the QA Lead CSP Release Operations / Sr. Manager CSP Release Operations.
- Coordinate cross functional investigations in case of complex root causes and work closely with manufacturing, packaging and lab operations, supporting departments and/or third parties
- Evaluate investigation, root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
- Report significant quality issues to regulatory agencies, according to local legislation (e.g. FAR and BPDR for US marketed products and other BOHs as applicable).
- Prepare and contribute to E-SQRT/AQRT to assure compliance with worldwide standards.
- Participation in operations, product and process teams and Daily Operations Review meetings.
- Can act as point of contact for ESQ and SCQ (i.e. local quality contacts in the market) for different processes.
- Approve master documents and SOP's.
- Prepare annual product reviews and quarterly trend reports.
- This position can be requested to participate in assignments defined by the QA Lead CSP Release Operations / Sr. Manager CSP Release Operations.
- The Quality Specialist Operations CSP Release Operations will respect the PGS vision, mission, values and behaviours in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time and cost.
- Support continuous improvement initiatives in the department to improve processes and act on key KPI's.
- EDUCATION, TRAINING AND/OR EXPERIENCE_
- Degree
- Formal education
Following, although not limiting, university masters are acceptable (or equivalent through experience): Bio Engineer, Pharmacist, Biology, Biochemistry, Biotechnology, Chemistry or Engineering.
- Specific knowledge and skills
- Good analytical skills
- 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 )
- Preferably experience in a manufacturing environment or packaging environment
- Experience with quality investigations and release of biological products or vaccines
Work Location Assignment:
Flexible
- De Pfizer site in Puurs is één van de grootste productie
- De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patiënten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo's._
- Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie._
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