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.
Adhere 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).
Hands-on contribution to building a LIMS system to transition to a paper-free lab.
Minimum 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, please contact Behruz Sheikh:
Behruz.sheikh@srgtalent.com
/
07949870690
#J-18808-Ljbffr
Behruz.sheikh@srgtalent.com
/
07949870690
#J-18808-Ljbffr
