Manufacturing Science Specialist

LessinesIFarmaceutische industrie

Functieomschrijving

Handles complex CAPA investigations related to manufacturing operations. In view of this:
- Uses Six Sigma and DMAIC methods where appropriate.
- Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).
- Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
- Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and procedures by defining, implementing and maintaining appropriate SOP’s and training.
- Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
- Defends investigations in front of regulators during audits.

Develops and leads projects that will improve yields, throughput & process efficiency, production process control and/or will reduce process variations. In view of this:
- Uses QbD, DIDOV, Lean and implements new technologies (including PAT) where appropriate.
- Conducts risk analyses for existing bulk manufacturing processes as well as for new/upgraded processes (Capacity increase, Change Request, …), evaluate and implement actions to mitigate/reduce the identified risks.
- Defines tasks/experiments to be performed, provides required documentation and leads the project from start to the implementation, including the submission preparation.
- Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by procedures within his organization. Ensures a thorough and timely handling of associated tasks and activities.
- Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and procedures by defining, implementing and maintaining appropriate SOP’s and training.
- Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
- Defends submissions in the role of recognized process expert.

As a recognized process expert:
- Is involved in technology transfers, CMO related activities
- Ensures training of personnel on Scientific & Technical topics

Profiel

- Master or PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry or equivalent by experience
- 3 to 5 years in Pharmaceuticals & Bio-therapeutics manufacturing, in a similar function
- Honest and responsible, flexible, customer focused, team player, open minded
- Critical thinking and Problem Solving
- GMP and bioprocessing knowledge and experience
- Experience with Technical writing (in English) in preparation of regulatory submission files and defending topics during an FDA or cGMP audit
- QbD, DIDOV, Lean, Six Sigma and DMAIC methods as appropriate

Organisatie- en afdelingomschrijving

For an international company in the pharmaceutical sector, we are urgently looking for a MANUFACTURING SCIENCE SPECIALIST

Aanbod

Open-ended contract

Heb je nog vragen?
Laure Delhaye HR Consultant Select Mont-Saint-Guibert +32 10 75 05 33
Manufacturing Science Specialist Vacature informatie
65127
zz archive Engineering / Technics
Vast contract
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