Senior QA Specialist - 12 month FTC
__jobinformationwidget.freetext.LocationText__
Dublin, County Dublin
- Operations
- On-Site
- Full-time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Primary duties and responsibilities of the position are as follows, other duties may be assigned:
- Responsible for implementing and maintaining the effectiveness of the integration of projects and NPI into the AbbVie quality system.
- Ensuring projects at AbbVie North Dublin meet the requirements of applicable regulatory requirements and AbbVie procedures and policies.
- Senior NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through commercialization, liaising closely with local and external cross functional teams to provide direction on quality concern and ensure appropriate mitigation to address potential risk.
- Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
- Support vendor evaluation and approval, management of all technical agreements from initiation review, approval and storage.
- Collaborate with local and above site functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understating 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, intermediate specifications, API specifications, Drug product specifications, raw material specifications and excipient specifications.
- Support the management of new project related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
- Generation of quality project documentation to attest the completion of project transfer deliverables, in advance of the applicable project stage review.
- Interfaces with internal and external stakeholders as the Quality subject matter expert for new projects / NPIs.
- Responsible for the coordination of Management review and presentation to site management team as directed.
- Responsible for the coordination of site QA Metrics as required.
- QA supports Market Expansions as associated change controls regarding assessment on behalf of the site and approval as such.
- Support QA specialist team when required to meet site compliance.
- Lead and Support Site Quality projects and drive to completion and due date.
- Track and trend of quality projects on site to management .
- Support onsite internal and external audits as required.
- Third level qualification in a science discipline.
- 5 years’ experience in the healthcare / pharmaceutical industry.
- A minimum of 3 years experience in a Quality role.
- Being QP eligible is desirable.
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:
- AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
- If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.
If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.
Protect yourself by verifying job offers and communications. Your safety is important to us.
Pay Range: $
-
Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.