West Lothian, Scotland
19 days ago
Our client one of the world's leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets are seeking a QC Analyst for a 1-year contract role based near Livingston.
The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.
To support the production of both development and market finished products under GMP conditions in all areas of quality control and calibration
Key responsibilities and accountabilities:
Actively involved in planning, executing and reporting analytical activities to determine fitness for purpose of starting materials, intermediate and finished products
Technically competent in analytical activities (e.g. pharmacopoeail wet chemistry, HPLC, GC, Dissolution) for QC testing of raw materials, packaging components and finished products.
Perform sampling of starting materials, packaging components and finished products
Perform cleaning verification analysis to assure suitability of Production equipment for subsequent use
Support calibration of key analytical equipment and measuring devices to agreed specifications
Participate in training laboratory personnel to a competent standard when required.
Prepare summary reports and Certificate of Analyses for approval
Prepare material specifications for approval
Perform duties as required to facilitate operations of the laboratory teams
Skills and Experience:
*Relevant qualification, HNC/HND/Science Degree or Equivalent
*An understanding of drug development and manufacturing processes
*Direct experience with pharmaceutical or biotechnology industry
*Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards
*Proven ability to work to key regulatory and compliance requirements
*Skilled in analytical techniques eg HPLC, Dissolution and Gas Chromatography
*Good understanding of quality control, SOP and GMP adherence
*Have a broad knowledge with and experience of working within a cGMP/GLP envronment.
*Experience of quality control within a pharmaceutical environment
*Experience of Chromeleon software
*Experience of data reporting and checking data within a QC environment
*Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.
*Computer skills: Must be competent in the use of MS Office, particularly Excel and Word,
*e-mail and internet
*Literacy and Numeracy: Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.
*Business Presentation Skills: Must be an excellent face-to-face and telephone communicator.