Quality Control and Validation Expert
We are seeking a skilled Quality Control and Validation Expert to join our team in Ireland. As a key member of our operations, you will be responsible for ensuring the highest quality standards in equipment qualification activities.
About the Role:
This is an exciting opportunity for individuals with at least 2 years of relevant experience in Validation Engineering or Quality Control. You will work alongside senior team members, assisting in maintaining quality standards and ensuring compliance throughout all equipment qualification activities.
Key Responsibilities:
* Support and assist with Quality Control compliance for equipment qualification activities, ensuring adherence to safety and regulatory standards.
* Help document and execute equipment qualification processes, from initial assessments to Operational Qualification (OQ), focusing on accuracy and attention to detail.
* Follow established procedures and protocols for new equipment qualification to help embed quality practices within workflows.
* Assist with the review and completion of Test Outlines and Procedures (TOPs), verifying alignment with quality specifications.
* Support the planning and organization of commissioning materials and consumables, ensuring they meet required quality standards.
* Monitor equipment qualification activities to ensure that timelines are met while maintaining high quality standards.
* Assist in preparing and maintaining Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards.
* Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on achieving quality outcomes.
* Assist in managing quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
* Collaborate with project contractors and equipment vendors to perform and verify tests, ensuring quality control is upheld.
Requirements:
* BS or MS in a relevant science or engineering field, or equivalent experience.
* 2+ years of industry-related experience in a similar role.
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
* Strong problem-solving skills with a focus on Quality Control.
* Customer-service oriented and able to collaborate well with internal teams and external vendors.
* Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience.
* Willing and able to travel domestically and internationally, if required.
Benefits:
* Pension Fund
* Medical Aid / Health Care
* Dental Care
* Income Protection
* Group Life Assurance