Senior Associate QA (GMP) (35351)

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 high possibility of extension. This is a hybrid role, where you have to be on site at least 2 days a week.

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.

Required Qualifications and skills

• Bachelor of Science Degree with relevant working experience or this position is also a good entry-level position for Master degree in Lifesciences.
• Preferred, but not required: previous experience in GMP/Pharma.
• MBO degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry for someone with a Bachelor or MBO degree.
• 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.
• Accurate mindset
• Fluent in 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@orion-jobs.com or contact Tim on 0044 7593448607

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