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CSV Lead

Employer
GI Group
Location
England, Hertfordshire, Stevenage
Salary
Negotiable
Start date
20 Jul 2022
Closing date
17 Aug 2022

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

CSV Lead
Permanent

Full time role based Stevenage, Herts 3 days per week and 2 days remote

Competitive salalry and Annual Bonus and excellent Corporate Benefits

Exciting opportunity to join an expanding Biopharmaceutical Company in a role where you will be responsible for authoring, executing, reporting and maintaining IT validation lifecycle activities within the framework of cGMP and in compliance with the company QMS requirements for computerised/automated systems used in the manufacture and testing of products.

For you; Excellent salary and benefits, performance related bonus as well as private healthcare & dental insurance, life assurance, pension and access to an employee share scheme along with the opportunity for flexible working.

Main duties and responsibilities;
* Lead validation activities on projects including defining the validation requirements to ensure compliance.
* CSV Lead is an expert in computerised systems validation to apply best practices for computerised systems implementation.
* Support authoring of User Requirement Specifications, & Authoring Design / Installation / Operational / Performance Qualification protocols / reports for validation.
* Lead validation projects & generated and execute Validation Plan.
* Perform CSV assessments for data integrity, electronic records/electronic signatures, GAMP categorisation and vendor assessments as required for each project.
* Support, Maintain, develop, implement, and monitor CSV policy and procedures for enterprise CSV to ensure that they reflect current industry thinking and are compliant to cGMP, corporate policies & quality standards manual and regulatory guidelines.
* Support maintenance of validated state for computerised systems (Operational changes) and their periodic reviews of validated computerised systems.
* Participate in audits as a CSV subject matter expert.
* Assist in the training of CSV requirements to all areas of the company where required.
* Participate and support regulatory authorities inspections.
* Provide updates to the CSV Manager and escalate any issues as they occur

Experience and skills;
* Extensive experience of CSV in a pharmaceutical manufacturing environment.
* Specialist knowledge of CSV derived through both practical experience and theoretical studies.
* A broad understanding of CSV validation principles in general and the GMP expectations as applicable.
* Experience of engaging and dealing project stake holders.
* Validation project management
* Demonstrate understanding of Computer Systems Validation (CSV) and Data Integrity (DI) requirements for regulated industries and its development life cycle approach
* Strong technical authoring skills
* Thorough knowledge of cGMP as applied in biopharmaceutical or related industry
* Proven ability to meet timelines, prioritise tasks and engage with stakeholders
* Good communication skills and the ability to train people if required in CSV

For further details, please contact us on 01707 247259

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.

Company

Gi Group is one of the world’s leading staffing solutions companies, providing specialist services for the development of the labour market. Gi Group’s specialist Pharmaceutical Division supply high quality temporary and permanent staff to Pharmaceutical and Biotechnology organisations nationwide.

Gi Group’s Pharma Team can support clients onsite or remotely from Gi Group central offices and are specialists in their field with experience within the Pharmaceutical, Biotech and CRO industry.

The Group is active in the fields of temporarypermanent and professional staffing, search and selection, executive search, outsourcing, training, outplacement and HR consultancy.

Thanks to our direct presence and strategic partnerships, we operate in more than 40 countries across Europe, APAC, the Americas and Africa.

Able to serve all kinds of clients, the Group has developed strong expertise in large and multinational organisations, for which it has implemented global solutions through specialist divisions and dedicated local and international teams.

Ranked globally as one of the largest staffing firms by Staffing Industry Analysts, the Group is also a global corporate member of the World Employment Confederation (formerly CIETT).

Find Us
Website
Telephone
01707 247259
Location
Gi Group - Pharmaceutical Division
James Taylor House
St Albans Road East
Hatfield
Hertfordshire
AL10 OHE
GB
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