Senior Associate QA (GMP) (33170)

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. This is a hybrid role, where you have to be onsite 3-4 days a week.

What will you do

As a Sr. Associate QA clinical manufacturing/clinical supply chain - Trainee QP, you will provide quality oversight in the clinical packaging area and you will be providing QA oversight on the supply chain of clinical trial products (including but not limited to study set up and distribution of clinical trial material), ensuring compliance with GDP and GMP requirements. You will be in direct contact with a wide range of stakeholders and be responsible for establishing effective working relationships with key stakeholders including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs. In addition, you will work closely with the clinical Qualified Person, and be included in the in-house QP training program.

Main Responsibilities

• In this role you act as a Sr. Associate QA - Trainee QP, you are mainly responsible to provide quality guidance for Investigational Medicinal Products assuring that GDP and GMP standards are maintained, and to support Clinical QA primary processes:
  • Responsible for batch review to support QP batch certification of Investigational Medicinal Product in compliance with EU and international regulations
  • Compliance review and approval of clinical label artwork
  • Responsible for assessment of temperature excursions during transport and at clinical sites
  • Assist in resolution of compliance and quality issues related to the manufacturing and transport of clinical products
  • Review and approve minor deviations ensuring all procedural requirements are met
  • Owning and generating operational SOP's and Work Instructions
  • Review of SOP's ensuring that Corporate, Site and Regulatory requirements are met
  • Responsible for preparation of monthly metrics
  • Identify issues and work cross functionally to ensure a solution
  • Participate in on-the-job training activities to explore the responsibilities of QP.

Requirements

• Master in Science degree, preferably in Life Sciences or related field.
• Ability to fulfil the requirements of EU directive 2001/83/EC article 49 (Qualified Person) after training.
• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
• Fluent in English.

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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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.