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QAV Engineer
Employer undisclosedRole managed by a recruiter
Coordination and execution of validation and quality assurance activities in a pharmaceutical facility, ensuring compliance with FDA, European cGMP, and GAMP standards.
20d ago
Experienced (8-12 years), Expert & Leadership (13+ years), Intermediate (4-7 years)
Contractor
Sligo, County Sligo, Ireland
Onsite
Role
What you would be doing
validation
quality assurance
procedure update
coordination
change control
continuous improvement
- 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.
- Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
- Coordinating activities to maximise the effectiveness of all of the team members.
- Completing all required training before executing a task.
- Generation of validation investigations and implementation of corrective actions.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
- Creation/Review/Approval of various quality documents and test data.
- Maintenance and tracking of validation equipment, if applicable.
- Generation of validation protocols and final reports to cGMP standards.
- Management of validation, exception event, and change control processes.
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Maintaining the overall cGMP compliance of the production areas.
- Generation/maintenance/execution of the Site Validation Master Plan.
- Performing cross training within the team and training of new team members.
- Documenting all activities in line with cGMP requirements.
What you bring
validation/qa
prioritising
multitasking
communication
troubleshooting
regulatory
- Requires extensive validation/Quality experience in medical device plastics processing, moulding or assembly operations.
- Capable of prioritising work and multitasking.
- Strong communication (written and oral), presentation and troubleshooting skills required
- Effective interpersonal and organisational skills.
- Extensive knowledge of cGMP and regulatory requirements relating to the medical device industry.
- Ability to work well both independently and in a team environment.
- Qualification and/or degree in engineering or scientific discipline.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- comprehensive background checks may be conducted as part of the hiring process, including screening for cgmp compliance.
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