Senior NPI Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
What you do is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are hiring a Senior NPI Compliance Specialist to join our NPI QA team at the Ballytivnan site. This role is responsible for ensuring that all new products introduced to the site meet the requirements of GMP end users Regulatory Authorities and AbbVie standards. The Senior NPI Compliance Specialist will be responsible for supporting new product transfers to the site from development through to commercialization liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
What you will do:
- Be responsible for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.
- Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
- Collaborate with CMC QA R&D S&T clients and other functional groups to maintain roles and responsibilities identify potential quality issues obtain an understanding of the quality compliance and provide input on quality concerns.
- Coordination of site review of new product related material specification documents including but not limited to in process BDS Drug Product raw material and excipient specifications.
- Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
- Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
- Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
- Adheres to and supports all EHS & E standards procedures and policies.
- Serve as a designee for the NPI Compliance Lead as required.
Qualifications :
What you will need:
- Minimum of 5 years experience in the healthcare pharmaceutical or biopharmaceutical industry
- A third level qualification in a science quality or relevant field
- At least 2 years experience gained within an aseptic processing environment ideally within a quality function
- High level of expertise in day-to-day quality and compliance decision-making
- In-depth knowledge of GMP requirements and regulatory frameworks
- Strong attention to detail and commitment to compliance and quality standards
- Ability to facilitate quality decision-making while maintaining a strong patient focus and upholding AbbVies reputation
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
