Job Description
A passionate and technically strong individual is sought by a dynamic pharmaceutical company to support their growing business.
This role offers the opportunity to work in a variety of areas across Quality and Regulatory, with a focus on supporting the US side of the business.
The Quality team has expanded due to recent growth, and this role is key in supporting quality systems, quality assurance activities, compliance, release of finished product, artwork and labelling, and investigations of product related issues.
About the Role
* Ensure compliance with cGMPs & Environmental, Health & Safety regulations.
* Execute all activities to the business' Quality Management System, including non-conformance investigations, deviations, change control, complaints, document control system, record retention & CAPA.
* Execute the finished product non-conformance process.
* Support document reviews to ensure timely release of finished product.
* Execute all regulatory updates to product labelling to ensure timely and compliant launch of finished products.
* Manage and execute all routine regulatory updates and submissions of finished product labelling.
* Create and maintain National Drug Codes & Universal Product Codes.
* Create and maintain Structured Product Labeling (SPL) for FDA submissions.
* Ensure the company and product are registered in the appropriate markets as required.
* Review and approve product labelling, patient package insert, and other product labelling.
Experience and Educational Requirements
* Minimum requirement: BSc in a scientific discipline and at least 4 years in a Quality Assurance role.
* Ability to effectively manage and participate in cross-functional problem-solving teams.
* Ability to work independently.
* Excellent teamwork and interpersonal skills.
* Ability to handle a variety of tasks simultaneously.
* Artwork review/Regulatory experience desirable.
* Strong knowledge of Quality Systems, Quality Assurance, cGxP, and regulatory affairs.