Pfizer QO Release Engineer Verpakking in Puurs, Belgium

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 production in case of quality deviations.

This position reports to the QA Lead within the Quality product team.

EDUCATION, TRAINING AND/OR EXPERIENCE

  1. Degree: University degree in a scientific discipline, preferably in Pharmacy

  2. Specific training and skills required

  • 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, ...)

  1. Nice to have
  • Preferably experience in a manufacturing environment or packaging environment

  • Experience with quality investigations and release of biological products or vaccines

PRINCIPAL ACCOUNTABILITIES

• Assure that products manufactured and packaged in Puurs and by Third Party Manufacturers to the Puurs plant meet Company and legal requirements.

• Assure that products purchased and used in the Puurs plant meet Company and legal requirements.

• Investigate 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.

• Evaluate root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.

• Evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager/QA lead.

• Operate and maintain the Quality Assurance systems.

• Review batch related manufacturing documentation for conformity.

• Approve master documents and SOP's.

• Prepare Annual Product Reviews and Quality Performance Review.

• Prepare necessary release documentation for your area.

• Design the test plans for products in your area.

• Support continuous improvement of products and processes through:

 Quality deviation investigation (events/QAR's)

 Trending of LIR, events and QARs

 Participation in operations, product and system teams and Daily Operations Review meetings

• Contribute to timely supply of products.

• Release authority:

 Product batches that meet Company and legal requirements (PQS, GMP etc).

 Every Quality Assurance Report (QAR) needs to be approved by the Quality Assurance Lead, Manager QA, SQOL or Opu QL as described in the effective SOP.

This position can be requested to participate in assignments as defined by the QA Manager /QA lead. Role Description

The role of QA Release Engineer is situated within the QA Operations team which is responsible for Quality Assurance of the operational activities related to the packaging of medicines at the Pfizer site in Puurs.

"As QA Release Engineer you are the primary contact for the Production department in case of quality deviations."

In addition, you will perform and document all necessary investigations to support assessment of the sterile product being acceptable and make proposals for continuous improvement of products and processes.

You report to the QA Lead in a packaging oriented organization.

Main Responsibilities

  • You will assure that products manufactured and packaged in Puurs meet cGMP and Company and Legal requirements.

  • You will investigate batches not meeting specifications and prepare recommendations to the QA Manager / QA Lead.

  • You 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 evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager / QA lead.

  • You operate and maintain the Quality Assurance systems.

  • You approve master documents and SOP's.

  • You review batch related manufacturing documentation for conformity.

  • You prepare necessary release documentation for your area.

  • You prepare Annual Product Reviews and Quality Performance Review.

  • You support continuous improvement of products and processes through:

  • quality investigations (deviations)

  • trending of deviations

  • participation in operations and system teams

  • You contribute to timely supply of products.

  • You can be requested to participate in assignments as defined by the QA Manager / QA Lead.

  • You release batches that meet Company and Legal requirements and in alignment with a Global Quality Network.

Qualifications

  • University degree in a scientific discipline, preferably in Pharmacy.

  • Experience in Production (preferably at least 3 years), quality investigations and release of biological products or vaccines is an advantage.

  • 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.

  • You are diplomatic but surely convincing within an assertive attitude.

  • You are a team player.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.