Senior Quality Assurance Specialist

Job description

Job Responsibilities;

  • Overseeing and giving quality direction for key areas such as: Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems.
  • The QA Specialist will ensure that strong procedures and programs are in place that adhere to regulations. 
  • Approving and reviewing of Quality Process Development/ validation documentation such as: DS/ QRAES documents, validation Plans, Protocols, IQ, OQ, PQ.
  • During new product introductions/ Technology transfer/ Process validation, you will act as point of contact and make decisions.
  • The QA Specialist will give input with the Change Control Review Board and oversee QA in regards to change control and Deviation/CAPA records.
  • Authoring, reviewing and approving SOPs. 

Job Requirements;

  • The QA Specialist will have a BSc. in a scientific/ Engineering discipline with 5 years relevant experience as an SME in Quality (pharmaceutical or biotechnology industry).
  • Good understanding of Validation and NPI
  • Experienced with change control, non-conformance, CAPA's, and validation practices.

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