JO-2305-515686

Quality Assurance Specialist in Mullingar

Cpl are once again supporting one of our client partners to help them with a critical hire for their Organic Polymer product manufacturing site in Mullingar.

This site has been fully operational since 2020 and due to a recent internal promotion to the site leadership team, there is now an opening in the company for an accomplished and highly experienced Quality Assurance Specialist to join the team.

The company themselves are part of a global brand leader in the design and production of Organic Polymers for sale and supply to the pharma and other related industries.

Based on-site in the facility in Mullingar Co. Westmeath, this is a strategically important role.

As the Quality Assurance Specialist, you will have gained extensive quality management experience in a related area (medical products/materials ideally to ISO 13485, EXCiPACT, or ICHQ7 standards),

You will have a previously proven ability to lead a multidisciplinary team through quality management procedures and training.

The ideal candidate for this Quality Assurance Specialist role will need to have experience working with cleanroom systems or within a cleanroom environment

If you are familiar with quality management system experience (ISO 13485, EXCiPACT, or ICHQ7 or relevant other stringent system) that is also a key requirement

As the Quality assurance Specialsit for the site, you will lead your team through quality systems audits and will be responsible for ensuring the upkeep and maintenance of the Quality Management System (QMS) and associated documentation.

The Quality Assurance Specialist will be capable of interacting with senior management and should be flexible towards working across different areas of company development.

In your role as Quality Assurance Specialist, you will deliver on a critical role within delivering product solutions which benefit the end-user and the customers.

 Responsibilities

•           Reporting to the Site Operations Manager, the Quality Assurance Specialist will be responsible for using problem-solving approaches and analytical skills to support day to day operations within Organic Polymer manufacturing

•           Lead a team of 3 QC Specialists

•           Monthly reporting of key metrics to Corporate

•           Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products

•           Provide guidance and work direction to other team members

•           Provide support to cross-functional teams

•           Lead risk management activities

•           Provide support to internal, regulatory body and customer audits and associated corrective actions.

•           Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share

Education & Experience:

•           5+ years of relevant experience (Medical Device/ Pharmaceutical) in quality engineering, including, process validation, measurement system analysis, root cause analysis.

•           BA/BS degree in a Scientific or Engineering discipline

•           Extensive experience in QNs and CAPAs.

•           Good understanding of Statistical Methods for Quality Assurance

•           General working knowledge of the six-sigma process methodology

•           Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards

•           Good written and oral communication skills

•           Excellent problem solving and analytical skills

•           Ability to handle multiple projects simultaneously in an unsupervised environment

•           Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.

•           You will have previously demonstrated knowledge in pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality etc)

•           Familiar and experienced with Quality Management & regulatory compliance requirements in alignment with the IPEC GMP and ISO 13485:2016.

•           During your career, you will have Proven experience in managing key elements of QMS e.g., Change

•           Management (MOC), NCR/process deviation, CAPAs, Supplier Management, Risk Management, auditing and handling of Customer complaints.

•           Understanding of equipment qualification and process validation requirements.

•           Experience with Medical Device Regulations including ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management)

•           Proven Project Management and Team Participation experience

•           If you were a Certified auditor qualification (e.g. IRCA Lead Auditor) this would be advantageous

If you are interested in this new opportunity and you are also available for an On-Site role in Mullingar (please note that this is not a hybrid role) then please send me your CV in the strictest of confidence and I’ll review and respond to you within 48 hours.

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