Corporate Lead Auditor
Share
Job Location:
Monthly Salary:
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Quality
About the Job
The CLA partners with site stakeholders/site quality leaders to ensure inspection readiness and high compliance level of all Xellia Pharmaceuticals sites critical vendors and CMO/service providers. This is ensured by continuous monitoring through internal/external audits of the mentioned parties.
Responsibilities
External/Internal Audits:
- Set-up and maintain policies/procedures defining external/internal audits process/responsibilities
- Contribute to preparation of the annual internal/external audit plans
- Assessment of new audit requests (ACRF)
- Perform internal audits at Xellia Pharmaceuticals sites per annual internal audit plan
- Support the sites for internal audit CAPA plan definition/implementation
- Conduct external audits at CMOs API manufacturers CLOs material suppliers medical device supplier clinical study providers logistic partners pharmacovigilance service providers and other partners/service providers as per company procedure
- Plan execute/participate write the audit report and follow-up on action plans for internal/external audits
- Escalate compliance issues with potential impact/risk for Xellia Pharmaceuticals business/company reputation and provide insights on how to address the gap relevant for Xellia Pharmaceuticals stakeholders/management as per company procedure
- Advise/ support consultants while performing external audits on behalf of the Xellia Pharmaceuticals (preparation audit execution CAPA plan agreement/implementation etc.)
- Contribute to preparation of trend reports
Part Time Lead Auditor (PTLA) Program:
Participate in the PTLA program
Mentoring of PTLAs and monitor PTLAs performance
Customer Audits and Regulatory Inspections:
- Ensure Xellia Pharmaceuticals inspection readiness through execution of the internal audit plan
- Assist the sites during customer audits/regulatory inspections and support in providing responses if requested
- Act as a subject matter expert during customer audits/regulatory inspections
Supplier Surveillance:
- Provide input/support from the audit perspective in establishing quality requirements prepare and approve policies/procedures
- Review contracts if deemed relevant
Other Responsibilities:
- Provide training as subject matter expert to internal stakeholders if deemed relevant
- Provide guidance and share solutions to Xellia Pharmaceuticals sites and external suppliers for compliance issues
- Consolidate gap assessments of findings across Xellia Pharmaceuticals sites to ensure that gaps are addressed globally
- Support the review of industry/regulatory trends and perform the impact assessment to the relevant Xellia Pharmaceuticals processes
- Attend global quality projects on behalf of CAC and give support from an audit perspective
What we offer
- Competitive compensation and benefit package
- Nordic-style culture dynamic teamwork good working atmosphere flexibility maintaining work-life balance
- Opportunity to learn and develop
- Stable international company background
- Multinational working environment
- Home office opportunity
Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infectives supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.
Recognized by the World Health Organization and the European Union for our critical medicines we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark we operate manufacturing sites in Copenhagen Denmark; Budapest Hungary; and Taizhou China with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years we are driven by purpose and progress.
With more than 1100 employees our impact starts from within. We offer a workplace where ideas curiosity and initiative thrive and where your role evolves with your ambition. Instead of rigid structures we provide real responsibility freedom to explore and support to grow. Together we shape not only the future of our company and the development of our people but also the health of communities worldwide.
Further information aboutXellia can be found at:
Connect with us onLinkedIn
Required Experience:
IC
Key Skills
- Auditing
- Time Management
- ICD-10
- Accounting
- Component evaluation
- Workers' Compensation Law
- SOX
- Microsoft Excel
- CPT Coding
- Internal Audits
- Medicare
- Bookkeeping
About Company
Xellia is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often life-threatening infections.
