Job Title: Quality Specialist
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The Quality Specialist is a vital member of our team within the Quality department, supporting GMP Quality Assurance activities. The role involves ensuring compliance with regulatory requirements and company standards.
Duties and Responsibilities:
* Review and approve production and analytical documentation to ensure conformance to SOPs, GMP, and regulatory requirements.
* Perform and review complaints and deviation investigations, change controls, and CAPAs.
* Create and maintain assigned SOPs.
* Compile data for reports and presentations, provide data interpretation, and draw conclusions.
* Complete audits to ensure compliance to SOPs, GMPs, and applicable regulations.
* Support product recalls and stock recoveries as necessary.
* Collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
* Identify compliance gaps and make recommendations for continuous improvement.
* Assist in the induction process for new starters and training of other staff.
* Foster a culture of compliance, efficiency, innovation, accuracy, and safety within the organization.
Requirements:
* Bachelor's degree in a relevant field (Science, Quality, Engineering).
* A minimum of 4+ years' experience in Quality Assurance, Quality Control, or Technical Operations within the Biological and/or Pharmaceutical industry.
* Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise.