Key Responsibilities
- Initiate and own Minor deviations related to Product Complaint Inspection (PCI) Area activities.
- Own training material related to PCI processes.
- Own work instructions related to PCI processes.
- Prepare metrics and own and maintain departmental performance boards.
- Perform assessments in support of complaint investigations (e.g. Return sample inspection and Safety Features verification).
- Partner with corporate product quality surveillance, assessors from other manufactoring sites and contracted partners to resolve product complaint investigations.
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
- Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.
- Bachelor’s degree in Life Sciences (or related field) with 2 years of experience in a GMP-regulated environment
- Strong analytical and problem-solving skills, with great attention to detail
- Knowledge of GMP and GDP with the ability to interpret and apply in both routine and non-routine cases
- Knowledge of Complaints Management, Deviations and Quality processes and systems
- Fluent in English, both spoken and written
- A dynamic and international work environment.
- Work 100 % on-site in Breda, full time. Part-time is not possible
- Competitive salary and benefits package.
- Travel expense reimbursement depending on commuting distance.
- Temporary contract through Undutchables to cover pregnancy and maternity leave (6 months).
Salarisomschrijving
€4700 - €4900 monthly
