QA Validation Engineer
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| Job Type | Contractor |
| Area | Sligo |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2213 |
| Job Views | 265 |
- Description
Team Horizon currently have two openings for experienced QA Validation Engineers at our client’s Biologics manufacturing facility in the North West. Reporting into the Validation Lead, you will actively participate in the site Validation Program and general Quality Assurance activities.
Why you should apply:
You’re passionate about your profession and strive for excellence in everything you do.
You’re ambitious and thrive in working environments where high standards and patient safety are key.
You bring new ideas to the table, are well versed in industry best practice and innovative talent solutions, and you will be integral to the continuous growth of the organization.
You want to work in a culture of innovation, inclusion and development, and you bring out the best in people.
What you will be doing:
Active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to cGMP standards.
QA support for validation investigations and implementation of corrective actions.
Creation/Review/Approval of various validation and qualification documents
Management of validation, exception event, and change control processes.
Documenting all activities in line with cGMP requirements.
Performing cross training within the team and training of new team members.
Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
Coordinating activities to maximize the effectiveness of all of the team members.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns
What you need to apply:
Bachelor’s Degree in science based or engineering discipline
3 years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area
3 years plus of knowledge of cGMP and regulatory requirements relating to the
pharmaceutical industry.
Strong communication (written and oral), presentation and troubleshooting skills required
Effective interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Capable of prioritizing work and multitasking.
