Validation Team Lead
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Job Type | Permanent |
Area | Sligo, Ireland |
Sector | EngineeringQuality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 2871 |
Job Views | 878 |
- Description
- Are you passionate about managing and leading people?
We have an exciting opportunity available for a Validation Team Lead for our clients pharmaceutical manufacturing facility in the Northwest.
Why you should apply:
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
What you will be doing:
You will lead, coach and mentor your Validations team to success
Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
Generation/maintenance of the Validation Master Plans.
Generation/maintenance of Project Validation Plans.
Generation of validation protocols and final reports to cGMP standard.
Review / approval of all protocols and final reports.
Management of validation change control process.
Adheres to and supports all EHS & E standards, procedures and policies
We believe in collaboration so in this role, you will partner with cross functional teams across the business
Any other duties as assigned
What you need to apply:
3rd level qualification in engineering or scientific discipline
3-5 years’ experience in a cGMP regulated environment, with validation activities demonstrated successfully.
Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.
Demonstrated leadership capability - experience building a strong diverse team and inspiring them to succeed.
This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned, and resolved.
Good communication and motivation ability is required.