Product Quality Manager
Proclinical are recruiting for a Product Quality Manager to join a biotech organisation. This role is on a permanent basis and is located in Belgium.
- Supervise the performance of the manufacturing and delivery procedures through metrics.
- Assist with the follow up of audits and inspections and guarantee suitable CAPA execution in a timely manner.
- Aid in further build-out of quality procedures and systems.
- Evaluate quality agreements with external parties.
- Help the HA inspection and work with both internal shareholders and external parties to prepare for said inspections.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Demonstrable experience within a quality assurance role, handling biopharmaceuticals with familiarity within biological manufacturing operations.
- Demonstrable experience with manufacturing and/or lab actions would be beneficial.
- Familiarity working within an outsourced model, in cooperation with a CMO would be advantageous.
- Acquaintance with audits and experience with preparing regulatory inspections such as FDA, EMA, PMDA, etc would be beneficial.
- Expertise on both FDA and EU guidelines and ICH regulations.
- Leadership abilities.
- Works well with others as well as independently.
- Communication skills both verbally and in writing.
- A versatile and flexible individual.
- Technical and analytical abilities.
- Precise in implementation and reporting, quality minded.
- Capable to work within a dynamic environment of a fast-paced setting.
- Fluency in the English language.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.