APL, A Comar Company, are a custom Injection Moulding company, delivering precision manufactured parts to the medical device, pharmaceutical and food sectors.
We currently have an exciting opportunity for the right candidate to join our Team as Validation and Quality Engineer.
We offer many benefits – we are passionate about investing in our people. We offer unrivalled training and development, offering our employees the opportunity to grow within the company.
APL is a great place to work, we are local, eliminating the time and cost of long commutes. We offer work-life balance – no requirement to do shift work. We also offer a profit share scheme and 26 days leave per annum.
We have a strong diverse culture – no two days are the same, allowing for an interesting and positively challenging career.
The Role Scope:
· Assist with the planning, co-ordination and support for the execution of validation activities.
· Ensure compliance to ISO13485, APL Quality Procedures and GDP. Assist with training staff on documentation and procedures as required.
· The design, analysis and approval of IQ, OQ & PQ protocols and reports.
· Liaising with Production and other departments to ensure adequate resources are in place to execute validation.
· Assist with ensuring validation timelines are accurate and achievable.
· As part of process improvement projects, prepare process validation protocols where appropriate.
· Create CMM programmes for products that are manufactured and generate SPC data for each production run.
· Assist with the handling of the documentation Software and Equipment validation
· Assist with the monitoring and control of calibration within the Company.
· Handling product and material trial documentation. Complete any dimensional studies that may be required in relation to trials or as specified by the customer.
· Support Department Managers with the understanding and implementation of GXP’s such as GAMP – Good Automated Manufacturing Practices; GDP – Good Distribution Practices etc.
· Assist with the development and analysis of quality metrics.
· Assist in carrying out internal audits and external audits where necessary in relation to preparing for audits, corrective actions and audit close out.
· Support and lead Continuous Improvement Programs /Projects as required.
· Assist with training as required such as induction or procedural changes to documentation such as work instructions, QAP’s, QSS’s etc. that may require training by liaising with Shift QI Trainers to aid with training completion.
· Complete Certificates of Conformance and batch summary reports after the completion of production runs.
Education
Science, Engineering or Quality Degree would be most advantageous. Must be capable of using his/her own initiative and requiring minimum supervision. Have a good level of computer skills i.e. Excel and Word.
Relevant Skills
- Good communicator
- Good interpersonal skills
- Work on own initiative
Job Type: Full-time
Additional pay:
- Overtime pay
Benefits:
- On-site parking
- Profit sharing
Schedule:
- Day shift
Ability to commute/relocate:
- Tinahely, CO. Wicklow: reliably commute or plan to relocate before starting work (required)
Language:
- English (required)
Work Location: In person
