Senior Quality Assurance Specialist

5 days ago

Manchester, United Kingdom SRG Full time
Job Title: Senior Quality Control Associate

Are you a seasoned quality control professional looking for a challenging opportunity to drive quality excellence in a contract pharmaceutical manufacturing organization?

This role is a fantastic chance to join a highly successful and award-winning company, renowned for its expertise in contract development and manufacturing.

Key Responsibilities:

  • Develop and execute U/HPLC method transfer, validation, and contribute to method development (Assay, Purity & Imps methods, Cleaning methods).
  • Conduct dissolution method transfer and validation, with a focus on method development.
  • Perform pharmacopeial methods such as IR, Appearance, pH, CU, and water content.
  • Ensure adherence to Good Manufacturing Practice (GMP) standards using a new electronic Quality System.
  • Contribute to the setup of the CDS and laboratory, and actively participate in building the LIMS system.
  • Write validation plans and reports, primarily for HPLC and Dissolution methodologies.
  • Write stability plans and reports.
  • Support activities to qualify equipment required for QC testing, ensuring compliance with current European Pharmacopoeia and ICH requirements, and participate in the calibration of analytical equipment as needed.
  • Contribute to the creation and review of Plans, Methodologies, Work Instructions, and Standard Operating Procedures (SOPs).
  • Contribute to building a LIMS system to transition to a paper-free lab.

Requirements:

  • Educated to Degree level in a relevant scientific discipline along with a minimum of 2 years' experience in pharmaceutical sciences within GMP development.
  • Experience in an analytical laboratory environment with a sound understanding of regulatory requirements.
  • Familiarity with OpenLab is desired.

About SRG:

SRG is the UK's leading recruitment company specializing in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals, and medical devices sectors.

We're passionate about providing outstanding temporary, contract, and permanent career opportunities for our candidates and expert strategic recruitment services for our clients.

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