Senior Associate QA (GMP) (33495)

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

Main Responsibilities of the role

• To perform QA review and Approval for SAP Master Data and artwork.
• To ensure QA systems are maintained, improved and performance is appropriately monitored.
• To establish effective working relationships with the Global Artwork Center, Master Data, SCPM, Site SME's and RA department, as well as QA Management.
• Perform review and approval of Master Data related activities (such as critical value verification and Bill of Materials).
• Perform approval of artwork for medicinal products.
• Act as author for operational SOP's and Work Instructions.
• QA Review of operational SOP's and Work Instructions.
• Participate in QA related projects as needed.
• Assist in various investigations as needed.
• Responsible for preparation of weekly/monthly metrics.
• Own and maintain departmental performance boards.

Required Qualifications and skills

• MBO or Bachelor's degree in Life Sciences or related field or the equivalent combination of education and/or experience. Entry-level position for Master degree in Lifesciences.
• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Fluent in English language.
• Accurate mindset
• Fluent in Dutch and English language.
• Problem Solving Skills:
  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
    • Ensures compliance within regulatory environment.
    • Develops solutions to technical problems of moderate complexity.
    • Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.
    • Interprets generally defined practices and methods.
  • Autonomy Skill:
    • Works under general direction
    • Work is guided by objectives of the department or assignment
      • Refers to technical standards, principles, theories and precedents as needed.
      • May set project timeframes and priorities based on project objectives and ongoing assignments.
      • Recognizes and escalates problems.
    • Contribution:
      • Contributes to work group/team by ensuring the quality of the tasks/services provided by self.
      • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
      • Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
      • Establishes working relationships with others outside area of expertise.

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.