QA Validation Engineer
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Job Type | Permanent |
Area | Sligo |
Sector | Quality |
Start Date | |
Advertiser | Darcy Ainscough-Denton |
Job Ref | #2395 |
Job Views | 176 |
- Description
We are currently recruiting an ambitious and experienced QA Validation Engineer for our clients Biologics / Fill Finish site in Sligo.
Why you should apply:- Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.
- The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
What you will bedoing:- Coordinate / direct and actively participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Generate/maintain/execute the Site Validation Master Plan and Project Validation Plans and schedules.
- Generate validation protocols and final reports to cGMP standards.
- Generate validation investigations and implementation of corrective actions.
- Create/Review/Approve various quality documents and test data.
- Manage validation, exception event, and change control processes.
- Maintain and track validation equipment, if applicable.
- Update validation procedures, job instructions and batch documentation to reflect current best practices.
- Perform cross training within the team and training of new team members.
- Maintain the overall cGMP compliance of the production areas.
What you need to apply:- 3rd level degree in engineering or scientific discipline.
- A minimum of 3 years validation/Quality experience in pharma/biopharma operations (Facilities, Utilities and Equipment).
- A minimum of 3 years of knowledge of cGMP and regulatory requirements relating to the pharma/biopharma industry.
- Ability to work well both independently and in a team environment.