Lead Quality Assurance Specialist

4 weeks ago

Manchester, United Kingdom SRG Full time

Are you a seasoned Quality Control professional eager to take on a pivotal role in enhancing the Quality Control Division of a contract pharmaceutical manufacturing company?

Position: Senior Quality Control Associate

Employment Type: Permanent

Compensation: Competitive salary with excellent benefits

Location: Northwest, England

SRG is proud to collaborate exclusively with a distinguished, award-winning contract development and manufacturing organization, dedicated to delivering expert intelligence and support to their partners, driven by their extensive capabilities.

Due to significant growth, we are seeking a skilled Quality Control Specialist to lead and enhance the quality testing functions within the QC Division.

Key Responsibilities:

  • Perform hands-on U/HPLC method transfer, validation, and contribute to method development (including Assay, Purity & Impurities methods, and Cleaning methods).
  • Conduct dissolution method transfer and validation, with a focus on method development.
  • Execute pharmacopeial methods such as Infrared Spectroscopy, Appearance, pH, Conductivity, and water content analysis.
  • Ensure compliance with Good Manufacturing Practice (GMP) standards utilizing a modern electronic Quality System.
  • Assist in the establishment of the CDS and laboratory, and actively engage in the development of the LIMS system.
  • Draft validation plans and reports, primarily related to HPLC and Dissolution methodologies.
  • Prepare stability plans and reports.
  • Support efforts to qualify equipment necessary for QC testing, ensuring adherence to current European Pharmacopoeia and ICH standards, and participate in the calibration of analytical instruments as required.
  • Contribute to the creation and review of Plans, Methodologies, Work Instructions, and Standard Operating Procedures (SOPs).
  • Actively participate in the transition to a paper-free laboratory by contributing to the development of a LIMS system.

Essential Qualifications:

  • A degree in a relevant scientific field, coupled with a minimum of 2 years of experience in pharmaceutical sciences within a GMP environment.
  • Experience in an analytical laboratory setting with a solid understanding of regulatory standards.
  • Familiarity with OpenLab software is preferred.

SRG is recognized as the leading recruitment agency in the UK, specializing in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable energy, biotechnology, chemicals, and medical devices sectors.

As professionals in the scientific field, our specialized knowledge and passion set us apart. This unique combination enables us to provide exceptional temporary, contract, and permanent career opportunities for candidates, along with a comprehensive range of expert strategic recruitment services for our clients.

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