Senior Associate QA (GMP) (34000)

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) (Product Complaint Inspection) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. This is a fully onsite position.

Objectives

• Perform complaint assessments at our client Breda in accordance with internal procedures, regulatory guidelines and business performance objectives.
• Own and/or act as QA contact for minor deviations.

Main Responsibilities of the role

• 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.

Required Qualifications and 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.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.