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Computer System Validation Specialist
3 months ago
This full-time permanent role is Hybrid, working two days a week in our client's Glasgow offices (Tuesdays and Thursdays) and three days a week from home (Mondays, Wednesdays, and Fridays).
Do you want to work for a founder managed, high growth & pioneering company who offer market leading purchasing and supply chain management services which ultimately allow Biotech, CRO & Academic organisations to focus on discovering life changing scientific innovations?
Are you already a CSV Specialist/Engineer with demonstrable experience of validating GxP software systems in the Life Science, Biotech or Pharmaceutical industry, including the generation and execution of all validation lifecycle documents?
If you have said yes to the above, then this new Computer System Validation Specialist role created due to our client's growthcould be the perfect career move for you
The responsibilities of the Computer System Validation Specialist – Life Sciences:
- Software evaluation: Assess the software functionality, identifying areas requiring validation and conduct detailed risk assessments to identify potential areas of non-compliance in the software
- Validation Lifecycle: Manage the full lifecycle of validation projects from initial assessment to post-validation summaries, ensuring quality and consistency at every stage
- Validation Strategy: Design and develop comprehensive software validation strategies and plans to ensure our software meets required standards and regulatory compliance.
- Validation Protocol Design: Create detailed validation protocols, in accordance with appropriate regulatory requirements, the companies Quality Management System and current industry practice
- Testing: Execute or oversee the execution of validation test cases, ensuring they adhere to the set protocols
- Documentation management: Generate, review, and maintain all necessary validation documentation
- Collaboration: Work closely with customers, Inventory Onboarding, and other internal teams to ensure synchronisation of efforts
- Regulatory Adherence: Stay updated on relevant industry regulations, standards, and guidelines to ensure that validation processes and documentation are compliant.
- Process Improvement: Review and optimise validation processes and methodologies, keeping abreast of industry best practices
- Incident Management: Report and address any Quality Management System noncompliance related to validation
The requirements of the Computer System Validation Specialist – Life Sciences:
- Demonstrable experience of validating GxP software systems in the Life Science, Biotech or Pharmaceutical industry, including the generation and execution of all validation lifecycle documents
- Proven ability to interpret, understand, and apply relevant guidelines, regulations, and standards to maintain validation compliance
- Bachelor's degree preferred, for example in a science or technology-based degree
- Comprehensive knowledge and understanding of the regulatory requirements including FDA 21 CFR Part 11
- Knowledge and understanding of Good Manufacturing Practice guidance
- Excellent communication skills and enjoys building rapport and relationships with internal teams and customers.
- Proven track record in managing and delivering projects with excellent organisational skills
- Strong willingness to champion validation processes and advocate for adherence to regulatory requirements throughout project lifecycles
Salary & Benefits:
- Annual profit-sharing scheme (between 9% – 19% of base salary)
- Private Pension (5% matched and rising to 8% after 5 years)
- 3x base salary in life insurance
- Hybrid working and flexible hours
- 22 days holiday + 9 bank holidays
- Laptop & Phone
Apply right now by calling Oliver Gill – Global Recruitment Manager at Langton Howarth Ltd on and email your up-to-date word CV to Langton Howarth is the market leading scientific supplies company placing people into dream jobs across the UK and Europe daily.
To be considered for this role you must have full right to work in the UK and a valid UK driver's licence.
Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate's name and contact details in confidence via email too, and we will ensure you receive £100.00 of vouchers from a high street retailer of your choice
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