Quality Engineer

The Role:

• Quality Engineer
• Kilkenny
• Onsite role some remote work may be possible at times but the role is designated onsite
• Permanent or Contractor opportunity

Role Brief:

Working with a major SL Controls client in the Pharma sector you will be responsible for the maintenance and management of a range of quality systems and protocols within a high tech regulated manufacturing environment.

Core Responsibilities:

• The development and maintenance of Quality System procedures.
• Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.
• Monitoring and maintaining the quality and compliance status of associated quality records.
• Maintaining the quality and compliance status of associated Procedures work instructions and training materials.
• Presenting and communicating status report metrics identify trends potential issues improvement initiatives as applicable.
• The review and approval of validation documentation in accordance with divisional policies.
• Basic understanding of design controls and design transfer.

Skills Brief:

• Strong experience in working with Quality systems for pharma life science or medical device manufacturing systems and largescale applications.
• 56 years working knowledge of process equipment facilities and or software validation either within Quality or Engineering departments.
• Strong understanding of cGMP requirements including 21 CFR 11 and Annex 11.
• Excellent understanding of GAMP principles and validation concepts.
• Demonstrated analytical and problemsolving capabilities.
• Strong technical writing skills.

Person Brief:

• Candidates must have a level 8 degree in Quality Validation Biotechnology Pharmaceutical Manufacturing or a highly related discipline
• 2 years experience in a Quality focused role in Pharma Life Sciences or Medical Devices is essential only candidates with this experience can be considered at this time
• The ideal candidate will have excellent collaboration and communication skills strong attention to detail and able to communicate and present effectively to various levels of leadership
• Ability to think logically and be proactive.
• Must be flexibly and able to manage multiple priorities simultaneously.
• Must have excellent organizational skills
• The ability to be onsite daily is essential. Some remote working may be available but the role is designated onsite and may require a full time onsite presence. Therefore you must be able to commute daily to the site.

Opportunity Brief:

This is an excellent opportunity to work with clients who are global leaders in their field helping to develop and improve upon industry leading technology solutions. SL Controls offers a supportive environment committed to employee development and wellness along with a competitive and rounded compensation package which rewards high performers.

Company Brief:

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers including many of the worlds top multinational companies in the medical device and pharmaceutical sectors achieve their Six Sigma and OEE targets.

Over the past 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway Limerick Leinster and Florida USA.

We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users OEMs and Technology providers.

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