Location: Cork Role: Permanent

Details:

Excellent opportunity to join an expanding quality team within a leading Pharmaceutical company. Reporting to the Quality & Regulatory Manager, you will be responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product related issues and regulatory affairs.

PRIMARY DUTIES AND RESPONSIBILITIES:
1. Ensures compliance with cGMP's & Environmental, Health & Safety regulations.
2. Ensure compliance to 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 of finished products.
6. Manages & executes all routine regulatory updates & submissions of finished product labelling.
7. Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
8. Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
9. Ensures the company and product is registered in the appropriate markets & with agencies as required.
10. Reviews and approves product labeling, patient package insert and other product labeling.

Experience

Minimum BSc in a scientific discipline (e.g. Chemistry, Biology or related field)
· At least 5 years’ experience in a Quality Assurance role within a cGMP environment
· Experience with CAPAs, deviations, change control and other core QMS processes
· Strong background in the pharmaceutical industry, ideally within a manufacturing setting
· Excellent written and verbal communication skills with strong attention to detail
· Proven ability to work both independently and collaboratively across cross-functional teams

· Strong problem-solving and critical thinking skills

· Proficient in Microsoft Office (Excel, Word) and Document Management Systems