Job Reference: J5631560
Updated On: 16/07/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a QA Project Specialist to join a leading Biopharmaceutical company based in the Berkshire area on an initial 6 month contract basis. As the QA Project Specialist you will be responsible for transitioning a Biopharmaceutical project from Clinical Development through to Commercialisation.
Key Duties and ResponsibilitiesYour duties as the QA Project Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for a range of activities including Technology Transfer, Process and Analytical Validations that will be in accordance to Regulatory requirements.
2. You will be working cross-functionally across different departments including Quality, Research & Development, Validation & Regulatory Affairs.
3. You will be responsible for the ensuring GMP compliance and implementing QMS procedures throughout the project duration.
4. You will be responsible for reviewing and approving Batch Manufacturing Records, Project Documentation and Regulatory Submissions.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Project Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biology based discipline
2. Proven industry experience working in GMP Quality Assurance environments within the Biopharmaceutical industry
3. A working knowledge and practical experience with Project Management within QA
Key Words: QA / Quality Assurance / Project Management / Biology / Therapeutic Protein / Antibody / Batch Documentation / QMS / Quality System / Technology Transfer / Validation / Process Validation / Regulatory / Submission / Manufacturing / GMP / CAPA / Deviation / Change Control / Market Launch
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.
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