You are accountable for releasing vaccine product to the market in accordance with Company and legal requirements. In addition, you will perform and document all necessary investigations to support assessment of the product being acceptable and make proposals for continuous improvement of products and processes. You are the primary contact for production in case of quality deviations. You report to the QA Manager/QA lead within the Quality product team.
- Monitoring the validation approach for all equipment (filling lines, autoclaves, inspection machines, HVAC, computer systems, laboratory systems, ...) of a full production unit.
- Monitoring the application of change management for equipment and process modifications to your unit, you do the final review of the impact analysis, validation plan and other actions.
- You are involved as a partner and validation authority projects for modifications and new installations.
- You are focused on product quality and compliance, securing a general awareness within the project teams.
- You work with the technical experts at a validation plan and do the final review of all system validation reports.
- You will be an active part of a quality product team, each with a focus on the various quality HINTS vaccine production. However, you are in close contact with Quality project engineers from other production units.
- You point to the product team for validation and change management expertise for which you build contacts with the relevant departments.
- You will assure that products manufactured and packaged in Puurs to the Puurs plant meet Company and legal requirements.
- You will investigate batches not meeting specifications and prepare recommendations to the QA Manager/QA lead.
- You will coordinate cross functional investigations in case of complex root causes and work closely with Production and supporting departments.
- You evaluate root cause analyses, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
- You will operate and maintain the Quality Assurance systems.
- You approve master documents and SOP's.
- You prepare Annual Product Reviews.
- You support continuous improvement of products and processes through:
- quality investigations (Events/QAR's)
- trending of events and QAR's
- participation in operations, product and system teams
- You contribute to timely supply of products .
- You can be requested to participate in assignments as defined by the Manager Quality assurance operations/QA lead.
- You release batches that meet Company and legal requirements and in alignment with a global quality network.
- University degree in a scientific discipline (preferably in Pharmacy), bio-engineering, industrial pharmacist, industrial engineering, ...
- Vaccine experience is required
- Experience in production (at least 3 years), quality department or testing and validation department within a GMP environment. Experience in releasing vaccines is a must.
- You are critical set but works constructively for solutions.
- You can work independently and make decisions
- You have very good analytical skills
- You have excellent communication skills both oral and written (Dutch/English)
- You have excellent documentation skills (technical report writing in Dutch/English)
- You have good project management skills (cost, time, scope); handling conflicting priorities
- Knowledge of IQ / OQ / PQ; HVAC; Cleanrooms; inspection equipment; testing; validation; FMEA; Fill media; Cleaning validation; Sterilization Validation; Change Control; quality systems; Computer Validation; ASTM E2500; is an added value.
- You are diplomatic but surely convincing within an assertive attitude.
- You are a team player
Please send your CV and cover letter to ingrid [dot] vanhemel [at] pfizer [dot] com