CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2’600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the US offers flexible and specialized solutions across five technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
As QC Documentation Specialist you will be working as part of the CordenPharma Brussels Quality Control Department. In this role you will review analytical documents and provide technical guidance to the QC technicians on all analytical techniques
Duties and responsibilities
- >> Review of QC analytical file to ensure compliance with data integrity principles (before submission to the production or QA department)
- >> Conduct analyses (raw materials, in-process control (IPC), finished products, stability samples) and instrument maintenance when required.
- >> Update analytical documents and QC management procedures
- >> Support the manager in collecting the necessary information to answer questions from authorities and customers
- >> Review validation documents or analytical method transfer documents from internal or external laboratory to ensure consistency with the QC laboratory practices.
- >> Actively participate in improvement projects within the QC as well as internal or external audits depending on the field of expertise.
- >> Be able to write deviations, OOS, CC or CAPA
Qualifications and skills
- >> Bachelor or Master degree in Chemistry or Biochemistry
- >> Min.5 years in a similar function in a GMP regulated environment
- >> Working knowledge of physico-chemical analysis techniques (HPLC, UHPLC, IC, GC, potentiometry, titration, UV, IR etc.)
- >> Excellent accuracy and attention to detail
- >> (c)GMP experience required with strong knowledge of (c)GMP applicable to QC.
- >> Organizational skills
- >> Excellent command of Microsoft applications
- >> Oral & written communication skills (French & English)
What we offer
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
Then we should definitely get to know each other. We look forward to receiving your application via the button Apply or send it to [email protected]