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Q Associate 30402

  • Job reference: 933646
  • Location: Breda, North Brabant
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Building, Construction & Infrastructure
  • Date posted: 22/01/2021

Orion Group Life Sciences are looking for a QA Associate for our Multinational Biotechnology client based in the Breda area on an initial 12 month contract with the potential to extend.

Please note that this is a 3 shift cycle role

Main Responsibilities of the role

  • Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.
  • Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
  • Review and approve batch production record data entries before production activities take place
  • Perform finished product checks during (commercial) production runs
  • Compile and review batch records for lots assembled, packaged and labelled and contract manufacturers in preparation for disposition by QP.
  • Review of operational SOP's and Work Instructions as needed
  • Review and approve deviation records
  • Initiate and own QA deviations as needed.
  • Perform GMP compliance checks in production
  • Assist in development and delivery of GMP training activities for QA and production staff
  • Participate in QA production related projects as needed
  • Assist in various investigations as needed
  • Assist in projects and improvement efforts as needed
  • Responsible for preparation of weekly/monthly metrics
  • Own and maintain departmental performance boards

Desired Experience and Background of the successful candidate

  • MBO or Bachelor's 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 with experience in batch record review and investigations.
  • 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.
  • Manufacturing and/or Quality analytical processes and operations.

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.