QA Project Specialist

Job Ref: J32447
Sector: Science
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 24 June 2019
  • Slough, Berkshire, England, UK Slough Berkshire UK SL1 3WE
  • Competitive
    ANNUM
  • UmulKulthum Ahmed
  • 0203 096 4529
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QA Product SpecialistContract: 6 months Location: Slough Salary: £50/hr

SRG are working with a Global Pharmaceutical Company who are looking a QA Product Specialist to join their therapeutic antibody team. The role is within the Quality Assurance organisation and is based in Slough, Berkshire for 6 months.

Dependent on the experience of the candidate, the scope of the role would involve:

  • Process validation, analytical validation, technology transfer, stability studies, comparability studies, shipping qualification and cell line characterisation in accordance with FDA and EMEA requirements.
  • The role entails working closely with scientists, regulatory affairs and QA, internally and with contract manufacturers, to provide advice, support, and troubleshooting on the studies to be performed.
  • A key component of the position is review and approval of project documentation and regulatory submission sections to ensure that the required regulatory and quality standards are met.
  • The review will include a high level of data verification, requiring the ability to assimilate complex project scenarios and drive the project program forwards with said focus on regulatory and quality requirements.
  • The candidate will also be required to provide the QA input for assessment and documentation of investigations, deviations and change controls, review of batch manufacturing records to support release of batches, and implementation of QMS procedures for commercial launch.

Requirements:

  • The candidate must be experienced in the pharmaceutical biologics industry with an understanding of the applicable regulatory requirements for development of therapeutic monoclonal antibodies.
  • Experience of working in GMP QA and submission of marketing authorisations is highly desirable. The candidate must be an excellent communicator, able to work both as part of a team and independently, with proven ability to meet timelines and work under pressure, and apply high standards to their work with close attention to detail.
  • Demonstrable evidence of complex project management within a QA context is highly desirable.

To find out more, please apply online or send your CV to directly to or give Umul a call on 0203 096 4529.

SRG
24/07/2019 16:46:39
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