QC Analyst (Fixed Term Contract)

 

Major Duties and Responsibilities

•Ensures that lab cleanliness and safety standards are maintained (Aseptic technique trained in Micro) •Ability to perform physicals testing of finished products, Raw materials & Components

•Performs analytical testing of Finished or Stability batches using validated HPLC methods

•Performs RM analytical testing or Micro/PET to USP, EP, BP monographs

•Identify and report equipment problems for Tech. support resolution

•Receive and inspect raw materials & Packaging components

•Revise standard quality control operating procedures & WRKs

•Identify and reports quality events & OOS/OOTs to line manager

•Ability to document all Chemistry, Micro or packaging analysis following good data documentation practice with minimal supervision

•(Expanding Proficiency)

•Trained & competent in multiple analytical instrumentation techniques, including HPLC, GC, Dissolution, conductivity/TOC, FTIR

•Ability to perform analysis consistently at a high RFT > 90%

•Demonstrates some competencies of QC instrument troubleshooting

•(Bridging Proficiency)

•Demonstrates independent data documentation, processing & trend awareness

•Ability to review data from physicals tests or basic HPLC or GC assays

•Performs report writing with minimal supervision e.g. Micro validation, end of stability reports etc.

•QC Assistant Analysts at expanding or bridging proficiency must also be able to demonstrate the following abilities:

•Business awareness

•Effective Communication •Problem solving

•Team Work · Undertakes such other reasonable duties as may be required from time to time to support the department and business activities. · Acknowledge responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.

Competencies

•To communicate instantly any problems/queries concluded by the Laboratory to the Quality Control Supervisor or QC and Stability Manager.

•Respond promptly to requests and concerns.

•Complete business objectives.

•Ensure the cleanliness and tidiness of your individual workstation and to ensure a standard of good housekeeping in all areas of the Company.

•Provide flexibility if required when requested to work out side of normal working hours.

•Ensure behaviours follow company policies and departmental expectations

Knowledge and Experience

•Minimum Expected Education-  Level 6 – Bachelor’s

•Additional Information-Degree University Degree; Typically no years work experience required, understanding of the basics of Pharmaceutical GMP. A minimum of two A levels or T Level in a scientific discipline plus more than 1 years analytical experience in a GMP laboratory.