# Sligo based role
GerTEK is an engineering consultancy company specializing in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
We're looking for a motivated equipment maintenance technician to join our dynamic engineering team. You'll play a key role in driving critical site projects, focusing on enhancing our site's sustainability, reliability, and efficiency. If you have a passion for equipment and have hands-on in a highly regulated environment, we want to hear from you!
Title: Quality Compliance Specialist
Purpose:
To coordinate the development and maintenance of company’s quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured meet requirements of end users, of regulatory authorities and of the company.
The Quality Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and company requirements.
Responsibilities:
· Supports coordinating the quality system, ensuring full compliance by all personnel with its requirements.
· Supports a Quality Risk Management approach for all site activities and participates during the coordination Risk Control Strategies (RCS) and FMEA activities as required.
· Auditing the quality system with other management personnel.
· Initiation and Completion of Quality related ERs as required.
· Providing quality guidance, support, and approval on all site/system validation activities.
· Ensuring that products manufactured at Ireland Pharmaceutical Operations
meet requirements of end users, of regulatory authorities and of the company.
· Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings e.g., SPM.
· Monitoring quality performance and advising management personnel on major quality issues.
· Ensuring all plant personnel are fully aware of quality and cGMP requirements
· Implementation review for Policy documents
· Supporting all aspects inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
· This position is crucial in identifying any causes of non-compliance of the quality system while maintaining effective communication with all employees.
· Adheres to and supports all EHS & E standards, procedures, and policies.
Responsibility for supporting the following activities (as assigned) within the Quality Department:
· The investigation of and coordination of exceptions by ensuring implementation of effective corrective / preventive action where necessary
· Product quality review activities
· Management of all technical agreements from initiation, review, approval, and storage
· The coordination and management of all track and trend activities to support manufacturing and QC
· Coordinating change control and Change plan activities
· Vendor evaluation, approval, re-evaluation
· Data gathering for Management Review
· Metrics gathering and reporting
· The evaluation of customer complaints
· Training of personnel
· Review and approval of quality and validation documents
· The drafting of CAPA plans in response to audit findings
· The drafting of quality plans to support quality improvement initiatives
· The tracking and implementation of CAPA tasks and quality plan tasks
Qualifications:
· A Third level qualification in a science, quality, or relevant discipline.
Job/Technical Skills
· A minimum of two years’ experience in a quality role.
· A strong knowledge of regulatory requirements is required.
Work Location - Onsite
Job Type: Full-time
Work Location: In person
