SRG - Senior QC Scientist

Job Title:

Senior QC Scientist

Category:

Technical roles

Closing Date:

31/01/2025

Senior QC Scientist – Analytical

Northwest, England

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.

For more information regarding this position or any others, please contact Behruz Sheikh : Behruz.sheikh@srgtalent.com / 07949870690