- BBBH765251 Jan 12, 2021 Competitive
Brilliant Quality & Regulatory opportunity for an experienced QA individual (5+ years experience) to join a growing organisation
Due to recent business growth I am delighted to be able to bring this new opportunity to market.
Over the last number of years this company has seen year on year growth and is expected to see additional products being added to their portfolio again this year. Due to this expansion they are on the lookout for a Quality Specialist to join their Cork team on a permanent basis. There will also be an element of Regulatory to this role.
This role will report into the Quality & Regulatory Manager, where your primary responsible will be for the quality systems and quality assurance activities and compliance with cGxP's. The successful individual will also be involved in the support release of finished product and investigations of product related issues and regulatory affairs. This is an office based role.
- Ensures compliance with cGMP's & Environmental, Health & Safety regulations.
- Ensure compliance & execute all activities to the Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
- Executes the finished product non-conformance process.
- Supports document reviews to ensure timely release of finished product.
- Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
- Manages & executes all routine regulatory updates & submissions of finished product labelling.
- Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
- Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
- Ensures the company and product is registered in the appropriate markets & with agencies as required.
- Reviews and approves product labeling, patient package insert and other product labeling.
- Executes the document control system & record retention.
- Develops, implements and maintains Standard Operating Procedures.
- Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
- Maintain familiarity with current regulatory trends.
Experience and Educational requirements:
- BSc in a scientific discipline preferred
- Minimum of 3 years in a cGMP facility in a Quality Assurance role.
- Experience in the Pharmaceutical industry is essential.
- Experience in Medical Device & Pharmaceutical regulations is desirable but not essential.
If you would like to be considered for this role or if you would like to hear more then get in touch today on 021 2300 300 or email@example.com
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300