Validations Manager
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| Job Type | Permanent |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | EngineeringManagement |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1003074 |
| Job Views | 205 |
- Description
- Team Horizon is seeking a Validations Manager for our client who are a global leader in the biopharmaceutical industry, for their Sligo site. In this role, you will be responsible for carrying out the development and maintenance of the client’s validation program and ensure the client and external regulatory, quality, and compliance requirements are met.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
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.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Coordination / direction and active participation in the validation and qualification of the client’s equipment, utilities, processes and software in compliance with client policies, FDA, European cGMP and GAMP standards.
Generation, maintenance, and 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, and 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.
Any other duties as assigned.
What you need to apply:
Bachelors/Masters degree in engineering or relevant scientific 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.
3 years plus of leadership experience. A minimum of 3 years’ experience in a cGMP regulated environment.
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.
A minimum of 3 years’ experience in a cGMP regulated environment.
