Contracting – Brabant Wallon
GMP Compliance
Functieomschrijving
Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:
- Ensuring that Quality systems are in place/in use, routinely monitored and assessed
- Mastering quality agreement content
- Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
- Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
- Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
- Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
- Identifying risks associated to the specific activities of the CMO
- Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities
Profiel
- University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
- Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
- Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
- Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
- Fluent in English and French
- Excellent communication (including presentation) and influencing skills.
- Stakeholders’ management: ability to interact with internal & external stakeholders
- Ability to travel to CMO (less than 1x/2month)
Aanbod
- Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres
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