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About the Role
This role is in support of BluePoint Laboratories, a Cencora business offering a trusted source of generic pharmaceuticals.
This is a fantastic opportunity in a role that blends hands-on Quality Assurance with Regulatory Affairs, giving you the chance to grow across both disciplines at the same time. The product portfolio is constantly evolving, from pharmaceuticals and medical devices to exciting emerging areas like biosimilars, so there is always something new to get involved in.
As a virtual operation, you will collaborate with colleagues across multiple countries, bringing real international exposure to your day-to-day work. A structured training plan is in place to set you up for success from day one.
Location: Little Island, Cork
Shift Pattern: 39 hours per week, Monday to Friday
Working Model: Hybrid, 2 to 3 days on-site, with the remainder from home
Key Responsibilities
- Ensure ongoing compliance with cGMP, Environmental, Health and Safety regulations
- Execute all Quality Management System activities including non-conformances, deviations, change control, complaints, CAPA, document control and record retention
- Manage and execute the finished product non-conformance process and support timely product release
- Lead regulatory updates to product labelling, ensuring compliant and timely product launches
- Create and maintain National Drug Codes (NDC), Universal Product Codes (UPC) and Structured Product Labelling (SPL) for FDA submissions
- Ensure company and product registration is maintained in all appropriate markets and with relevant regulatory agencies
- Review and approve product labelling, patient package inserts and associated documentation
- Develop, implement and maintain Standard Operating Procedures (SOPs)
- Monitor Key Performance Indicators (KPIs) to track performance and identify opportunities for improvement
- Stay current with evolving regulatory trends and requirements
- Promote and maintain a safe, healthy working environment
.
Skills and Experience
Essential:
- 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
Desirable:
- Experience in Regulatory Affairs, particularly around labelling and submissions
- Familiarity with Medical Device regulations
- Experience with Artwork review and/or Supplier Quality
What's on Offer
- Competitive salary
- Annual performance bonus
- Private healthcare coverage
- Company pension scheme
- A genuinely varied role combining Quality Assurance and Regulatory Affairs in one position
- International exposure through a virtual, cross-country working environment
- Structured onboarding and training plan to support your success from day one
- Opportunities to work on exciting new product areas, including biosimilars
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies: BluePoint Laboratories
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
