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QA Specialist

Employer
Hyper Recruitment Solutions
Location
Hertfordshire
Salary
Experience Dependent
Closing date
11 Jun 2019

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Job Details

We are currently looking for a QA Specialist to join a leading gene therapy company based in the Hertfordshire area. As the QA Specialist, you will be responsible for ensuring compliance to GMP and GCP standards, and lead the batch manufacturing activities.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA Specialist will be varied. However, the key duties and responsibilities are as follows:

1. You will lead batch manufacturing activities, reviewing and issuing BMRs and labels, facilitating batch disposition in conjunction with the QP and the release of raw materials cross-functionally.

2. As the QA Specialist, you will liaise with third party manufacturers and providers in the management of Quality Technical Agreements and the maintenance of Product Specification Files

3. You will manage deviations, quality investigations, CAPAs and change controls, and review and approve shipment temperature data, SOPs, validation protocols and reports.

4. As the QA Specialist, you will ensure GMP and GCP compliance through leading internal audits, trending and tracking quality metrics and KPIs.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA Specialist, we are looking to identify the following on your profile and history:

1. Relevant Life Sciences degree.

2. Proven industry experience working with Investigational Medicinal Products within Quality Assurance in a GMP environment.

3. A working knowledge and practical experience with Advanced Therapy Medicinal Products and Quality Assurance in a GCP environment.

Key Words: QA / Quality Assurance / ATMP / Advanced Therapy Medicinal Products / IMP / Investigational Medicinal Products / cGMP / GMP / Good Manufacturing Practice / GCP / Good Clinical Practice / Compliance / BMR / Batch Manufacturing Record / Batch Release / QTA / Quality Technical Agreement / PSF / Product Specification File / Deviation / CAPA / Change Control / SOP / Validation Protocol / Audit

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.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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