Are you an experienced QC Specialist looking for an exciting new challenge to help shape the Quality Control Department of a contract pharmaceutical manufacturing organisation?
Job Title: Senior QC Scientist – Analytical Type: Permanent Salary: Highly attractive with great benefits Location: Northwest, England SRG is currently working exclusively with a highly successful, award winning, contract development and manufacturing organisation, focused on providing expert intelligence and support to their partners, driven by their capabilities.
As a result of rapid expansion, we are looking for another experienced QC Specialist to help lead and grow the quality testing capabilities of the QC Department.
Typical responsibilities/accountabilities: Execute hands-on U/HPLC method transfer, validation, and contribute to method development (Assay, Purity & Imps methods, Cleaning methods).
Conduct dissolution method transfer and validation, with a lesser focus on method development.
Perform pharmacopeial methods such as IR, Appearance, pH, CU, and water content.
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.
Writing validation plans and reports, primarily for HPLC and Dissolution methodologies.
Writing 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.
Contribution to the creation and review of Plans, Methodologies, Work Instructions, and Standard Operating Procedures (SOPs).
Hands-on contribution to building a LIMS system to transition to a paper-free lab.
Essential 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.
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