CSV Officer

Employer
Hyper Recruitment Solutions
Location
West Yorkshire
Salary
Not specified
Closing date
16 Jan 2022

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Job Details

Are you looking to move your career into Computer Systems Validation? If so, we have a fantastic opportunity for a CSV Officer to join a global pharmaceutical business based in West Yorkshire.

As the CSV Officer you will primarily be responsible for the development and execution of qualification and validation packages, test scripts and protocols.


KEY DUTIES AND RESPONSIBILITIES:

Your duties as the CSV Officer will be varied however the key duties and responsibilities are as follows:

1. To implement cGMP, MHRA and FDA requirements across IT GxP systems and to ensure compliance to these and current best practices. Write, approve and/or support Policies and Procedures regarding computerised systems and ensure adherence to these and other related Policies.

2. Write and execute system validation documentation including; Risk Assessments, FDS VAP, URS, UAT, IQ/OQ and PQ. Review and maintain the Site Validation Master Plan.

3. Provide CSV advice and recommendations to stakeholders as required. Participate in activities/projects as CSV subject matter expert. You will also be required to support internal and external auditors, such as the MHRA or FDA.

4. Management of the validation life cycle of IT manufacturing business systems including:
a. Environmental monitoring systems
b. Serialisation and decommissioning systems relating to the Falsified Medicines Directive
c. Systems supporting manufacturing and packaging operations


ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the CSV Officer we are looking to identify the following on your profile and past history:

1. You will be degree qualified in a relevant Scientific, IT or Engineering discipline and have a good understanding of Computer Systems Validation.

2. The successful candidate will have a broad range of knowledge in systems/applications relevant to pharmaceutical manufacturing or a similar highly regulated manufacturing environment, such as Medical Devices or Life Sciences. A knowledge of cGMP would be beneficial.

3. A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT hardware, software architecture and IT infrastructure concepts is essential.


Key Words: Computer Systems Validation | CSV | Validation | Pharmaceutical | cGMP | Quality | GxP | IT


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: 
Twitter
Facebook
Linked in
Google +

Find Us
Website:
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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