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Senior Quality Assurance Specialist
2 months ago
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.
