Senior Associate QA (GMP) (33395)

Orion Group Life Sciences are looking for a Senior Associate QA (GMP), on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension.

Main Responsibilities

• Sampling and Inspection of Inspected Drug Product (IDP) and Finished Drug Product (FDP), and review completed batch records ensuring all procedural requirements are met.
• Sampling, inspection, review and release of printed and non-printed packaging components.
• Review and approve minor deviations related to incoming quality assurance and warehouse activities.
• Review temperature data of shipments received at ABR.
• Additional sampling and Inspection of materials or drug products as needed.
• Perform damage inspection on received drug product and materials as needed.
• Perform reserve sample inspection in support of complaint and deviation investigations.
• Provide QA oversight for:
  • Issues upon receipt of components and product.
  • Destruction Authorizations.
  • Cancelled Ship Confirmed Orders.
• Own training material and work instructions related to IQA processes.
• Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
• Collect data and initiate follow up with suppliers of our client for receiving issue resolution in collaboration with the External Supply team.
• Ensure Inspected Drug Product (IDP) and Finished Drug Product (FDP) batches are ready for release by the Qualified Person (QP) and all procedural requirements for release have been met.
• Execute sampling, inspection, review and release of incoming materials.
• Review and approve minor deviations related to incoming quality assurance and warehouse activities.
• Perform reserve sample inspection in support of complaint and deviation investigations.
• Establish effective working relationships with warehouse, QA management and others outside area of expertise.

Requirements

• MBO or Bachelor's degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically, 3 or more years of related experience or Master's degree or equivalent.
• Fluent in English language.
• Experience with pharmaceutical industry.
• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Understanding and application of principles, concepts, theories and standards of technical/scientific field.
• Keeps overview but also deep dives when appropriate.
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Good attention to detail and sufficient technical writing skills.
• Good decision-making skills and ability to apply risk-based approach.
• Team player, constructively working together towards solutions.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.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.