Summary: Orion Group Life Sciences is seeking a Senior Associate QA (GMP) for a multinational pharmaceutical/biotechnology client in Breda. The role involves performing complaint assessments, managing minor deviations, and ensuring compliance with regulatory guidelines. This is a fully onsite position with an initial 12-month contract and a strong possibility of extension.

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 sites of our client and contracted partners to resolve product complaint investigations.
• Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
• Assist in projects and improvement efforts of our client as needed.
• Provide training to staff in Breda and affiliate staff of our client on performing investigations/assessments.
• Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.
• Additionally, gain subject matter expertise in product complaint inspections and its related stakeholders.

Key Skills:

• MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• 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.
• Acquired practical experience in Good Manufacturing Practice (GMP) over at least 2 years.
• Acquired practical experience in Quality Assurance or related field in pharmaceutical industry over at least 2 years.
• Experience in investigations, deviations and Quality systems is a plus.

Salary (Rate): £26.45

City: Breda

Country: Netherlands

Working Arrangements: on-site

IR35 Status: undetermined

Seniority Level: undetermined

Industry: IT