Validation Technical Leader (Computerised Systems Validation)
* Full time, Permanent
Who We Are
Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.
Skills and Attributes
* Computer System Validation
* Quality Compliance
* Quality Systems
* High Attention to Detail
* Data Integrity
Description
Validation Technical Leader (Computerised Systems Validation)
Hours: 37.5 Monday-Friday with core hours 10:00-16:00.
Business Unit: Sciences
Open To: Internal & External Applicants
Ref No.: HRJOB10245/2
The Role
The primary purpose of this role is to perform activities within the validation lifecycle of all GMP systems requiring computerised systems validation. This role is specifically in relation to Computerised Systems Validation (CSV) in accordance with pharmaceutical industry regulations and guidance. Systems will range from standalone equipment to complex multi-site enterprise level systems e.g. Delta-V Distributed Control Systems, Chromatography Data Systems, ERP, LIMS etc.
The post holder will be a positive role model, demonstrating excellence in technical and practical knowledge, customer care, planning, QA and results delivery. The role may require staff supervision.
This role assumes an excellent understanding and demonstrated knowledge of CSV, including Data Integrity, within the validation lifecycle. This allows the Technical Leader to not only perform their own activities but also provide advice to others from system selection through to delivery and ongoing compliance, including change management. The post-holder will be considered the CSV SME and will be required to attend and present at technical meetings and audits/inspections.
Key Requirements
Applicants must have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK.
1. Degree (or equivalent) in Analytical Chemistry, Chemistry, Biochemistry, Engineering, IT or a related field OR significant relevant experience may be considered in lieu of Degree Level Qualification.
2. Significant Experience in a CSV role within the Pharmaceutical Industry.
3. Experience Reviewing and approving cGMP Validation Documentation.
4. Understanding of Pharmaceutical Industry Regulations and Guidance related to CSV/DI, including change management.
Apply Now
Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.
Closing Date
We will no longer be accepting applications after 8PM on Wednesday 30 April 2025.
Almac Group is an Equal Opportunity Employer.
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