Do you wish to push your career further with the chance to grow inside an international pharmaceutical company, and have the qualifications and professional background mentioned hereunder, than look no further!
Our client, a renowned pharmaceutical company is looking for a qualified Quality Assurance Manager.
Job description
The role of the Quality Assurance Manager (QAM) is to develop, establish and oversee the QA systems and processes within the clinical research group. S/he will support and work with the clinical study management team and teammates across R&D, laboratory, pharmacovigilance, regulatory and manufacturing.
Responsibilities
You will have a various selection of responsibilities, e.g.:
- You manage the QA department, which consists of 2 people, within the clinical research group.
- You get the responsibility to direct and control the installation, maintenance and adherence to appropriate quality system in full compliance with national and international regulatory requirements on clinical research.
- You oversee and develop the quality management system; you coordinate the development, revision, implementation and traceable distribution of quality documents (e.g. SOPs).
- You maintain an up to date and in-depth knowledge of appropriate national and international GCP/GxP legislation and guidelines; and assess the impact to assigned business area processes and procedures.
- You are a reliable source of reference and a leading example for employees seeking council regarding quality issues within the clinical research group.
- You perform GCP audits including but not limited to investigator sites, internal processes and vendors.
- You support deviation identification, reporting and CAPA development.
- You assist in readiness preparation and directly support regulatory agency inspection.
- You work closely with clinical study management team to provide expert clinical compliance information, managed identified issues, and support continuous improvement.
- You handle multiple projects and ensure overall and timely completion of tasks.
- You generate and provide metrics, status and trend reports.
- You oversee the training needs of the clinical research group and manage the data protection related activities and information (GDPR).
- You represent QA in all operational meetings related to the area of responsibility.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Profile
- Master Degree in Pharmacy, Science, or an engineering discipline or equivalent level of knowledge, understanding and hands-on experience of Good Clinical Practice in the pharmaceutical environment.
- Minimum 5 years' experience in the QA pharmaceutical sector.
- Fluent in French and English.
- Strong knowledge of European regulatory regulations, GxP and Quality Systems is required.
- Ability to handle audit situations and interaction in a tactful, professional, and effective manner.
- Ability to lead and facilitate group discussions in a constructive and positive direction.
- Self- organized, pro-active, and solution-oriented
- Proficient in Microsoft Office suite. Access knowledge is an asset.
Benefits
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17546
