Head of Process Valid&raw Material - Waremme, België - Mölnlycke

Mölnlycke

Geverifieerd bedrijf

Waremme, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

This opportunity will give you the chance to join a dynamic team in a healthy environment where you will never have the same day twice You will have a variety of activities and will never get bored.

If playing with numbers gets you excited this position is definitely for you. This position will offer you the possibility to grow vertically or horizontally and be continually stimulated and challenged.

As a Head of Validation, you will manage one Quality Control person under your team.

Through your responsibilities, you will also be the Head of Raw Material, Process Validation Owner, and Software validation process coordinator.

This position will give you the chance to take all necessary decisions concerning any risks of the products, including stopping operations.

Your responsibilities:

As Head of Validation, your role will be very varied and will cover:

Head of Raw Material:

Support adequate documentation for raw material (quality agreements and material specification) and maintain direct contact with suppliers to reach expected material quality level.
Coordinate the incoming material control activities : QC incoming inspection, reporting, control methods, etc.
Support Raw Material supplier audit program

Validation Process Owner:

Develop and support validation process as part of local QMS, according to ISO standard and global corporate procedures.
Manage appropriate users trainings.
Maintain the Factory Validation Master Plan (VMP) and keep uptodate properties list and impact tables
Provide validation protocols and select the properties to be validated
Collect data from validation studies and compile the validation report for approval
Maintain all validation documentation in accordance with local QMS and Process validation summary report in the PLM system
Act as change control process coordinator for Waremme Factory operations (management of change control notification)
Provide input into project phases related to Waremme Factory operations, for new launches (product, material, machine, process) and for changes projects.

Software validation process coordinator:

Develop and support software validation process as part of local QMS, according to global corporate procedures.
Maintain the Factory Computerized Validation Master Plan
Manage appropriate Software Owner trainings.
Provide input, guidance and support to software Owners.
Present validation systems (process & software) during internal and external audits

Your qualifications:

Relevant Master degree in Science or Engineering
A minimum of 5 years Manufacturing Process Validation experience in an established Quality function in the Pharmaceutical or Medical Devices industry.
Fluent in English and French