Description
- Participate in projects and improvement efforts- Own, review and approve SOP's and other GDP/GMP documentation and records (e.g. Validation, Change Control, NCs and CAPAs), ensuring that Corporate, Site and Regulatory requirements are met.
- Act as QA contact for commercialization and variation management activities, including New Product Introductions
- Disposition batches labeled and packaged at ABR
Minimum Requirements
- Pharmacist degree (or equivalent through experience) is required (e.g. BIG registered)
- Knowledgeable and skilled to fulfill the requirements of EU directive /EC article 49 (Qualified Person) and GDP guidelines 2013/C 343/01 (Responsible Person).
- Typically 3+ years of related professional experience
- Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
- Relevant experience in dealing with Non Conformances and Change Control records
- Preferred Requirements
- Customer oriented and service minded
- Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
- Good problem solving skills