Scientific
Scientific

QC Specialist

Pirbright, Surrey

Scope

An exciting opportunity has arisen to work for one of the world’s largest and fast-growing pharmaceutical companies. My client is looking for a talented QC Specialist to join their Quality Control department, on a permanent basis.

Responsibilities

  • Testing and allocation of reference samples for raw materials, excipients and primary packaging used in the site manufacturing process
  • Actively participate in Continuous Improvement initiatives that will improve efficiencies and cost savings across the QC department
  • Challenging existing methodologies of testing on site to both bring in line with EU GMP requirements and with EP monographs. Project manage through Change Control and Lean tools to deliver compliance and process improvements on time and in budget
  • Scheduling third party testing facilities regarding In- vivo and chemical testing of final vaccine products to ensure batch release is completed against planning commitments
  • Support with planning and completion of vaccine stability and release testing program. Communicate results and raise/investigate OOS events as required
  • Carry out all duties fully respecting GMP, Biosecurity & HSE standards
  • Participate in site quality systems in terms of raising, investigating, and closing QCC relevant deviations and Out of Specs. Perform RCA investigations and develop/close out relevant CAPA
  • Writing and developing quality documentation such as SOP’s, raw material specifications and study protocols as required
  • Support with the site utilities testing program (water and steam) and support the QC team with the site Environmental Monitoring program as required.

About You

  • Experience of working in a regulated, pharmaceutical environment is preferable.
  • Knowledge of biologics processes through education or industrial experience is preferred.
  • There is a need for day-to-day decision making in collaboration with line manager and support functions.
  • Life Sciences or Chemistry Degree preferred
  • Experience of working in an analytical laboratory and a good knowledge of GMP/GLP.
  • Good organizational skills and ability to work in a team and as an individual.
  • Ability to work methodically and carefully according to tight deadlines.
  • Reasonable IT skills.
  • Good knowledge of Quality Systems in a Bio/Pharma environment.
If you are interested in the above role then please apply or get in touch to discuss further.
Jak Thompson Managed by Jak Thompson
highlights
South East
Permanent
Scientific
apply Posted - 17.08.2021

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