Responsibilities of the QA Officer Clinical Products
As QA Officer Clinical Products you provide QA support for clinical products received and distributed from the Breda site to clinical sites and depots. You’ll be joining a dynamic and highly skilled team and might get the opportunity to evolve to a QP!
Your tasks include:
- Responsible for completing the Receipt Approval process for clinical incoming products
- Responsible for assessment of temperature excursions at clinical sites and transfers;
- Review and approve completed expiration date re-labeling and labeling
- Compliance review and approval of clinical label artwork;
- Assists in resolution of compliance and quality issues related to the transport of clinical products;
- Owning and generating of operational SOP’s and Work Instructions according to corporate, site and regulatory requirements;
- Participate in internal audits as needed;
- Assist in the development and delivery of GMP training activities;
- Assist in various investigations as needed (including complaints);
- Assist in validation activities as needed including review of validation documents;
- Participate in global and local quality improvement initiatives and support implementation activities.
Profile of the QA Officer Clinical Products
- Master degree in Life Sciences, preferably (industrial) pharmacy or biomedical science
- First experience in Quality Assurance or manufacturing in the pharmaceutical or medical device industry is an asset, but not necessary
- You have a good knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) (or willing to learn) with the ability to interpret and apply in (routine) cases;
- You are fluent in English language, knowledge of Dutch is highly demanded
Offer for the QA Officer Clinical Products
Our client offers a permanent contract within a growing international company.
With an on-site GYM, sports fields and in-house catering service, the client creates an inspiring work environment with a focus on vitality!