QA Project Specialist

5 days left

Location
Berkshire
Salary
£45 to £55 per hour
Posted
03 Jul 2017
Closes
31 Jul 2017
Ref
J4107
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
We are currently looking for a QA Project Specialist (Commerical Quality) to join a Life Sciences company based in the Berkshire area. As the QA Project Specialist you will be responsible for providing Operational QA support with regards to Drug Product / Drug Substance development, technology transfer and manufacture in GMP environment.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA Project Specialist will be varied however the key duties and responsibilities are as follows:

1. Provide support on operational and commercial QA activities to the site's cross functional teams working on Drug Development, Technology Transfer, Manufacture and Submission preparation.

2. Review and Approval of Project Documentation with regards to Technology Transfer and Reports.

3. Responsibility for Quality Agreements, Review of completed CMO batch documentation. Deviations, Change Controls, CAPAs.

4. Project Documentation for Process Development Studies, Analytical Validation Studies, Stability Studies. Alongside working closely with the Technical Operations teams.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA Project Specialist (Commerical Quality) we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific Discipline.

2. Proven industry experience with Pharmaceuticals, Drug Development and Manufacture in a GMP environment, Biologics or related.

3. A working knowledge and practical experience with Technology Transfer, Quality Assurance and Vendor Assurance within the Life Sciences, Pharmaceutical, Biopharmaceutical or related industries.

Key Words: Quality Assurance / GMP / Pharmaceuticals / Drug Product Manufacture / Drug Substance Manufacture / QA Officer / SOP / Documentation / Batch Documentation / Technology Transfer / Protocols / Reports / Reviews / CMO / Deviations / Change Controls / CAPA / QA Specialist

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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