Quality Specialist - office - wfh hybrid, Cork
Client:
Morgan McKinley
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
2b0bc2275258
Job Views:
144
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Job Description
A dynamic and successful pharmaceutical company is in search of a passionate and technically strong individual to join their growing business.
If you enjoy a varied workday focusing on different areas across both Quality and Regulatory, then this could be a great opportunity for you!
Due to recent growth, the Quality team has expanded and this team is key in supporting the US side of the business. As part of a core working team, you will be supporting quality systems, quality assurance activities, compliance, release of finished product, artwork and labeling, and investigations of product-related issues.
A bit more about the role:
1. Ensures compliance with cGMPs & Environmental, Health & Safety regulations.
2. Ensure compliance & execute all activities to the business' Quality Management System such as non-conformance investigations, deviations, change control, complaints, document control system, record retention & CAPA.
3. Executes the finished product non-conformance process.
4. Supports document reviews to ensure timely release of finished product.
5. Executes all regulatory updates to product labeling to ensure timely & compliant launch of finished products.
6. Manages & executes all routine regulatory updates & submissions of finished product labeling.
7. Creation and maintenance of National Drug Codes & Universal Product Codes.
8. Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
9. Ensures the company and product is registered in the appropriate markets as required.
10. Reviews and approves product labeling, patient package insert, and other product labeling.
Experience and Educational Requirements:
1. Minimum requirement of a BSc in a scientific discipline and a minimum of 4 years within a Quality Assurance role.
2. Ability to effectively manage and participate in cross-functional problem-solving teams.
3. Ability to work independently.
4. Excellent teamwork and interpersonal skills.
5. Ability to handle a variety of tasks simultaneously.
6. Strong knowledge of Quality Systems, Quality Assurance, cGxP, and regulatory affairs.
If you would like to find out more about this role, or are looking for a confidential discussion on the market, reach out to Kellie below.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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