COMPANY DESCRIPTION, PROFILE AND SCOPE OF ROLE:
Our Client is well established Global Pharmaceutical manufacturer, and world leader in their field.
This role represents an excellent career opportunity for an experienced Analytical Chemist.
Working with the analytical Coordinator and Analytical services Manager, the successful candidate will liaise with manufacturing, technical and operational quality personnel on relevant aspects of compliance and analytical atypicality, and will also liaise closely with the process managers, development chemists, Manufacturing, Pilot Plant and Quality, as well as customers.
KEY DUTIES & RESPONSIBILITIES:
• To perform analysis and report results in accordance with cGMP requirements for laboratory operations.
• To investigate analytical deviations and out of specification results with appropriate rigour and to contribute to their root cause resolution.
• To organise calibration and maintenance of analytical equipment.
• As required, to perform routine auditing of laboratory areas.
• As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
• To perform technical transfers between internal and external customers.
• To support method validation programs.
• To support cGMP stability programs.
• To characterise reference materials for use in cGMP analysis.
• Develop, evaluate and prepare analytical methods and SOPs as required.
• Ensure cGMP/GLP compliance
• Comply with all HSE requirements including safety policies and procedures, with particular reference to compliance within the analytical laboratories.
• Conduct HSE audits and housekeeping audits.
• Ensure safe laboratory operation.
• Manage individual process budgets to agreed costs and timelines.
QUALIFICATIONS, EXPERIENCE, SKILLS AND ATTRIBUTES:
• Minimum: good honours degree in analytical science or several years’ experience
• Preferably experience in ICPMS
• Working knowledge of cGMP
• Good verbal and written communication skills
• Excellent laboratory skills
• Good knowledge of IT