Samenvatting
- Bedrijf
- Harvey Nash plc
- Locatie
- Belgium, Antwerp
- Sectoren
- Biotechnologie/Farmaceutica
- Type job
- Voltijds
- Beperkte duur
- Relevante werkervaring
- 5 tot 7 jaar
- Carrièreniveau
- Manager (Manager/Teamverantwoordelijke)
- Referentiecode
- 161505_1280237935
QC team Supervisor
Harvey Nash is currently looking for a QC team supervisor for one of its customer.
Function description
The executor of this mission will in his/her expertise fields :
· Drive the team composed of 2 technicians (2 consultants to be hired) for the validation activities for a new vaccine
· Define planning for the team and write the validation documentation aligned with our procedures.
Key Responsibilities
In his/her expertise fields :
· Manage a clear planning for the team and himself training before testing, according to our customer procedures. Record the training using peoplesoft software
· Knowing the testing procedures and the FDA question to answer, write in English the validation protocols
· Ensure compliance with policies, processes and guidelines
· Support team on day to day job and protocols application (2 technicians in Belgium)
· Provide data analysis and a complete validation report with old an new data according to FDA questions in due time.
Prerequisites
Education: University level (biotechnology, chemistry).
Knowledge
· Good knowledge of validation for psyicochemitry technics (like spectrophotometry) and PHLC
· Bilingual French/English.
· Very good knowledge of cGMP (US & EU) in his/her expertise fields.
· Good understanding of Windows XP, Lotus Notes/Outlook, SAP.
Skills:
· Strong communication skills.
· Achievement oriented.
· Analytical skills, creative and critical mind.
· Autonomous.
· Ability to work in team in a multidisciplinary environment and a matricial organization.
Experience
Experience in QC Laboratory in the pharmaceutical industry is useful.
