Place : Neuchâtel
Language : English & French
THE ROLE :
This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the manufacturing site
Perform batch record review and prepare batch release documentation.
Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility.
Reviews and approves as QA representative qualification and validation activities documents (protocols, reports ).
Represents QA within department and cross-functional project teams according to assignments.
Acts as backup for colleagues within QA Operations team
YOUR PROFILE :
Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
At least 3 years of experience in a pharmaceutical company or other related industry.
BS or MSc in Science or related field.
Good understanding of cGMPs and FDA regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
Proven interpersonal, collaborative and organizational skills.
If this sounds like your next challenge could you please send me your updated CV at maryline.fonteyne akka.eu / (+41 78 980 99 63) and I will call you to discuss it in more details.
Alternatively, if you think this position could benefit someone you know, please do not hesitate to fwd it and cc.