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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