4 months ago
Ireland - Remote
Germany - Remote
United Kingdom - Maidenhead
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 74,000 people.
At Abbott, we know that laboratories performing at their best, deliver results that drive better patient outcomes and improve healthcare value. To help our customers achieve measurably better healthcare performance, Abbott has created a new way — an approach that delivers personalized solutions. By leveraging our resourceful advocates, harmonized systems and intelligent insights, Abbott Diagnostics (ADD) helps redefine performance in laboratories and institutions.
Abbott Diagnostics is recruiting for an experienced, life sciences auditor.
The Senior QA Auditor will independently conduct assigned audits of Suppliers and TPMs to assess compliance to all applicable External Standards and Regulations as well as Abbott’s own Quality System requirements at a standard commensurate with regulatory external audits. This individual may participate in audits of manufacturing and commercial affiliate sites too.
The Senior QA Auditor is responsible for implementing and maintaining the effectiveness of the quality system, ensuring compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues and offering strategic solutions to complex quality issues. They will independently lead audits across ADD's Supplier and TPM network, identifying compliance risks to current standards/regulations and may guide in the planning and execution of Quality System improvements. They will be able to provide expert guidance and training to more junior colleagues as well as leading on ad-hoc cross-functional projects, championing new initiatives and acting as a catalyst for change.
Candidates must have a Bachelor's degree in Life Sciences, Engineering or a closely related discipline. Experience in the life sciences/medical device/pharmaceutical industry is required. The ideal candidate will have an in-depth knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc. and will be trained in auditing techniques, with a Certified Auditor qualification or equivalent necessary. Excellent written and verbal communication skills are required.
Candidates can be located anywhere within UK, Ireland, Germany, Netherlands or Italy, with the UK preferable. This is a remote-working role, with approximately 40% global travel.
As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
Ireland : Remote
Germany : Remote, United Kingdom > Maidenhead : Remote
Ie - 06.0Hst0 (Ireland)
Yes, 50 % of the Time
SIGNIFICANT WORK ACTIVITIES: