- Reference: CJ44380
- Job Type: Contract
- Location: Cork, Munster
- Category: Engineering, Technical & Manufacturing
Objectives of Position:
- The primary objective of the role will be to Identify, define & implement key processes and system improvements such that they are closed loop.
- Improve site compliance and adherence to GMP/GxP
- Process mapping, procedural review and development, work instructions review and deployment site wide.
- Support QMS integration activity across the site
- Approvals as defined on Oracle
- Support the Quality System to ensure on-going compliance and continuous improvement. This role will liaise with various departments to ensure the quality system is in compliance
- Participate in local change and CAPA boards
- Ensure timeliness of ECR’s/SCN’s/CAR’s/PAR’s/SCAR’s, Customer SCAR’s,
- Developing and implementing systems for sustainable compliance and to ensure the system can then be maintained.
- Focus on key processes, complete a gap analysis, define the appropriate fixes, gain agreement & implement these improvements
- Conducting Audits to ensure conformance and effectiveness of the Quality System.
- Data and trend analysis and reporting.
- Ensures activities and items are in compliance with both company quality assurance standards and applicable regulations.
- Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
- Ensure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations.
- Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.
- Observes and monitors the trends relating to systems and processes and initiates improvements.
- 5 – 10 years’ experience in Medical / Regulated Industry.
- 5 – 10 years Technical Functional / Manufacturing experience (i.e. Eng., QA, Validation, Standards and Systems)
- Engineer, Technical or Quality Degree Qualified.
- Action Oriented – ability and proven implementation skills
- Sound understanding and utilization of Problem Solving Techniques
- Proficient in the use of Microsoft Word, Power-point and Excel.
- Good Communications and influencing skills. This position will require a result focused resilient personality who will identify opportunities for improvements and change, who will realize those improvements in a fast-paced growth focused Medical Device regulated environment, leveraging on his/her strong interpersonal skills.
- Experience in working within a Class 3 Medical Device Manufacturing Environment.
- Six Sigma Green or Black Belt Certified.
- Experience of report writing and requirements.
- Experience in New Product Introduction Processes.
- Experience in Agile
- Measurements will be tracked against plant metrics
- Improvement is site compliance QPI.
- Observed reduction in CAR generation.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
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