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AS&T Senior Validation Specialist

Merseyside   •  Negotiable  •  Contract/Temporary, Full time


AS&T Senior Validation Specialist

12 month contract

19.50 per hour

Liverpool

Cpl Life Sciences are recruiting for a AS&T Senior Validation Specialist to join our clients leading global Pharmaceutical company in Liverpool on a 12 month contract.

The main purpose of the AS&T Senior Validation Specialist is to work in the laboratory focusing on the optimization, development and validation of compendial microbiological methods including Microbial identification, Endotoxin, Bioburden and Sterility assays and molecular methods including RT-PCR.

Key responsibilities;

Performs tests in accordance with established methods and properly documents test results

Provides guidance /training to other lab staff as required

Authors protocols and reports for suitability studies and investigations to support testing and compliance issues

Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards

Creates and maintains standard operating procedures (SOPs), risk assessment and other documentation as necessary

Documents quality issues and performance measures for management review

Uses technical expertise to overcome analytical issues

Makes data supported decisions on project progression

Leads and develops a strategy, plans and manages project delivery

Documents project work as detailed lab book records or under technical protocols and reports as appropriate

Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements

Disseminates project findings/status updates at regular meetings/ forums within Global AS&T

Qualifications/ experience;

Bachelors degree in a relevant scientific discipline with 3-4 years experience

Masters with 2-3 years experience

PhD with 1-2 years experience

Has experience in validation of compendial microbiological assays (required)

Has experience of supporting regulatory submissions

Demonstrates ability to work in a regulated environment (biologics, diagnostics or other) - experience of applying ICH Q2 Validation principles or ISO/WHO equivalent

Experience of transfer of assays across labs/Sites

Please apply within or for more information contact Amy.goddard@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Amy Goddard
  • Reference: JO-2109-475638
  • Posted: 3rd September 2021
  • Expires: 1st October 2021

Cpl Life Sciences

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