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Quality Assurance Specialist

1 month ago

Deeside, Flintshire, United Kingdom SGS Full time

Job Title: Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at SGS. The successful candidate will be responsible for ensuring that all pharmaceutical products meet the highest standards of quality and compliance with regulatory requirements.

Key Responsibilities:

  • Oversee the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with GMP and other regulatory standards.
  • Conduct internal audits and support external regulatory audits, ensuring compliance with FDA, EMA, and other regulatory body requirements.
  • Work closely with the production and Quality control departments to provide guidance.
  • Review and approve batch manufacturing records and batch analytical records, ensuring accuracy and compliance with SOPs.
  • Review of analytical testing raw data and reports, including data generated from HPLC, Karl Fischer, TCC etc, ensuring data tables are CofAs are compliant with associated specifications.
  • Monitoring of product shelf-life and approval of changes.
  • Investigate deviations, non-conformities, and out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs).
  • Ensure that all quality documentation, including standard operating procedures (SOPs), risk assessments, and validation protocols, are up to date.
  • Prepare and submit reports on quality performance and metrics to senior management.

Requirements:

  • Bachelor's degree in Chemistry, Life-Sciences, Pharmaceutical Sciences, or a related field.
  • Knowledge of GMP, regulatory requirements, and quality management systems.
  • Excellent attention to detail and ability to maintain high standards of accuracy.
  • Strong problem-solving skills and ability to work under pressure to meet deadlines.
  • Proficiency in using quality management software and Microsoft Office Suite.
  • Good communication and interpersonal skills, with the ability to work collaboratively across departments.