JOBS IN LIFE SCIENCES

Release engineer

Ref. 20181119
Function: As release engineer you are the primary contact for a specific department in case of quality deviations.
Location: Located between Brussels and Antwerp

The company:

The company innovates to bring treatments to the patient which significantly improve their lives. 

The company wants to contribute to a better health and well-being of everyone at every stage of life. Together with the government and other health partners, they work on quality, affordable and accessible healthcare. For this the company has a strong product portfolio that brings both prevention, treatment and cure of diseases in a wide range of therapeutic domains. In addition, the company has a solid pipeline of promising new products that have the potential to battle with diseases that determine our view of the world of today today.

Job description:

The role of release engineer is situated within the QA operations team which is responsible for quality assurance of activities related to the production of aseptic products.

As release engineer you are the primary contact for a specific department in case of quality deviations.

Specific departments/primary contact in case of deviation for:
Release Engineer QC: Chemical and Microbiological Laboratory
Release Engineer Utilities: black utilities, clean utilities, electricity and HVAC
Release Engineer Packaging
Release Engineer QA: Production

In addition, this position will perform and document all necessary investigations to support assessment of the product being acceptable in accordance with cGMP and company and legal requirements and make proposals for continuous improvement of products and processes.

This position reports to the QA lead within the quality operations team.

Main Responsibilities:
• You assure that products manufactured and packaged meet cGMP and company and legal requirements.
• You 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 several 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 release pharmaceutical products manufactured on site.
• You operate and maintain the quality assurance systems.
• You approve SOP's.
• You prepare annual product reviews and quality performance review.
• You support continuous improvement of products and processes through:
o quality investigations (deviations)
o trending of deviations
o participation in daily operation review meetings, 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.

Requested competences and skills:

• University degree in a scientific discipline, preferably in Pharmacy.
• Experience in a laboratory, production or a GMP environment (preferably at least 3 years), quality investigations is an advantage.
• You have very good analytical skills.
• You have excellent communication
• Experience in a laboratory, production or a manufacturing environment (preferably at least 3 years), quality investigations 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.
• You are stress-resistant and flexible. 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. 

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