Job Description
A dynamic and successful pharmaceutical company is in search for a passionate and technically strong individual to join their growing business
If you enjoy a varied work day 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 on quality systems; quality assurance activities; compliance; release of finished product, artwork and labelling; 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 labelling to ensure timely & compliant launch
6. of finished products.
7. Manages & executes all routine regulatory updates & submissions of finished product labelling.
8. Creation and maintenance of National Drug Codes & Universal Product Codes
9. Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
10. Ensures the company and product is registered in the appropriate markets as required.
11. Reviews and approves product labelling, patient package insert and other product labelling.
Experience and Educational Requirements:
12. Minimum requirement of a BSc in a scientific discipline and a minimum of 4 years within a Quality Assurance role.
13. Ability to effectively manage and participate in cross-functional problem-solving teams
14. Ability to work independently
15. Excellent teamwork and interpersonal skills
16. Ability to handle a variety of tasks simultaneously
17. Artwork review/Regulatory experience desirable
18. 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.
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