My client a Cork based Medical company requires a QA Engineering Specialist
This individual will be a key member of the QA Audit & Compliance team.
Key duties of this role include (but not limited to) :
- Ensuring all QSE Management System procedures and records are reviewed & authorised.
- Work with Regulatory Affairs/Legal Manufacturer reps to identify requirements to ensure :
- All manufacturing location validation and processes meet legislation 2017/745 (MDR) requirements.
- Providing assistance and support in the preparation and maintenance of the QSE site manuals.
- Ensure all documents are in line of the ISO 9001, OHSAS 18001, ISO 50001 standards.
- Preparing & participating in external audits conducted by the DOE, EPA, HSA ETC..
- Providing constructive evaluation of quality related systems from suppliers
- Suppliers can include API, contract labs, excipient suppliers, commodity / logistics suppliers etc..
- Major responsibilities include.
- Assess compliance of systems, facilities, and procedures per applicable regulations.
- Perform audits & assessments of suppliers, assuring compliance to reg requirements.
- Provide feedback in the form of audit observations, and review corrective actions (CAPA's).
- Participate in strategic initiatives to improve compliance to reg requirements and standards.
- Education & Experience :
- Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology etc.
- Knowledge of technical standards & regulatory requirements for Europe, USFDA, a distinct advantage.
- At least 2 years) with sufficient exposure to pharmaceutical, medical device, or combination of.
- Must have a technical background & understanding of the audit process.
- Knowledge of worldwide requirements related to GMP regulations for quality systems & compliance.
- Understands a variety of quality/operational systems that support facility, product design etc..
An excellent salary is on offer.
For more information please mail firstname.lastname@example.org
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