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Job Description
Job Title: Pharmaceutical Supplier Auditor
Location: UK or Ireland Remote
As a member of the Supplier Auditing team within the PSG Global Supplier Quality organisation, you will be a motivator to the global supplier audit management and supplier qualification processes at Thermo Fisher.
The Auditor will also have experience in Pharmaceutical and/or Medical Device manufacturing or similar field, possessing technical capabilities, problem solving knowledge, and project management skills.
You will have work independently, collaborate, influence, and drive decisions at the right level. This position will provide an opportunity to develop expertise in supplier qualification and auditing as well as other developmental opportunities.
Essential Functions:
Work with the global manufacturing/services network acting as a liaison to ensure all Pharmaceutical Services Group (PSG) suppliers (material and service) continue to deliver quality products and services to the company.
Participate in the PSG Global Supplier Quality (GSQ) team, performing supplier audits, maintaining supplier audit reports and managing / negotiating CAPA responses.
Lead communication related to supplier audits with suppliers and impacted sites.
Maintain audit plan status, handling Global Supplier Quality Agreements, and communicating with suppliers where appropriate to achieve these tasks.
Plan, perform and coordinate the auditing process which includes timely completion of audits and agreements in the appropriate electronic-Quality System (TrackWise).
Lead or participate in PPI projects and initiatives to develop and implement improvements in GSQ. Responsible for reviewing cGMP documentation and may be responsible for authoring cGMP documentation, developing and delivering training for GSQ related topics.
Support with supplier quality, auditing and change notification activities and liaison with respective functions.
Education:
Experience:
Proven experience in a GMP environment, in any of the following industries: Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements, is required.
Understanding of cGMPs and regulatory requirements as they apply to the pharmaceutical field or a related area.
Knowledge and use of Quality Compliance Systems (Trackwise, etc).
Matrix organisation experience.
Experience with supplier auditing and supplier quality management.
Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered.
Competencies:
Knowledge of regulatory requirements and cGMPs, such as FDA, EU, ISO.
Strong interpersonal skills (verbal and written), including technical writing.
Appreciates and respects diversity, cultures, and norms.
Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint).
Confirmed self-starter with strong time management skills and the ability to work within a team as well as independently.
Multi-task and respond to shifting priorities.
Ability to learn new software and tools quickly and able to perform all qualifications and job responsibilities within a multi-site, global, remote team.
Able to travel across Europe up to 50% of the time.
Benefits
We offer great remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an appealing company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.