QAV Engineer
- Ireland, Midlands (Ireland)
- Contract
- CAPEX Projects
This vacancy has now expired
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a QAV Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow.
Responsibilities:
- Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards.
- Generation/maintenance/execution of the Site Validation Master Plan.
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- Generation of validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various quality documents and test data.
- Management of validation, exception event, and change control processes.
- Maintenance and tracking of validation equipment, if applicable.
- Completing all required training before executing a task.
- Documenting all activities in line with cGMP requirements.
- Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
- 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.
- Maintaining the overall cGMP compliance of the production areas.
Requirements:
- Qualification and/or degree in engineering or scientific discipline.
- 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical 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.
- This position is crucial in identifying systems and processes requiring validation/quality assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion.
- Good communication and motivation ability is required.
If this role is of interest to you, please apply now!
#LI-JS4
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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