reputed company: Corporate reputed company Auditor (11348)

Corporate reputed company Auditor reputed company The CLA partners with site stakeholders/site reputed company leaders to ensure inspection readiness and high compliance level of reputed company reputed company sites, critical vendors and CMO/service providers. This is ensured by reputed company 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)
• reputed company internal audits at reputed company 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 reputed company plans for internal/external audits
• Escalate compliance issues with potential reputed company/risk for reputed company business/company reputed company and reputed company insights on how to address the gap relevant for reputed company stakeholders/management as per company procedure
• Advise/support consultants while performing external audits on behalf of the reputed company (preparation, audit execution, CAPA plan agreement/implementation, etc.)
• Contribute to preparation of trend reports

Part Time reputed company Auditor (PTLA) Program:

• Participate in the PTLA program
• Mentoring of PTLAs and monitor PTLAs performance

Customer Audits and Regulatory Inspections:

• Ensure reputed company inspection readiness through execution of the internal audit plan
• Assist the sites during customer audits/regulatory inspections and support in providing responses, if requested
• reputed company as a subject matter expert during customer audits/regulatory inspections

Supplier Surveillance:

• reputed company input/support from the audit perspective in establishing reputed company requirements, prepare and approve policies/procedures
• Review reputed company, if deemed relevant

Other Responsibilities:

• reputed company training as subject matter expert to internal stakeholders, if deemed relevant
• reputed company guidance and reputed company solutions to reputed company sites and external suppliers for compliance issues
• Consolidate gap assessments of findings across reputed company sites to ensure that gaps are addressed globally
• Support the review of industry/regulatory trends and reputed company the reputed company assessment to the relevant reputed company processes
• Attend global reputed company reputed company on behalf of CAC and give support from an audit perspective

reputed company offer:

• Competitive compensation and benefit package
• "reputed company-style" culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and reputed company
• reputed company international company background
• Multinational working environment
• Home office opportunity

reputed company is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying reputed company Pharmaceutical Ingredients (reputed company) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries. Recognized by the reputed company and the European reputed company 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 reputed company 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 reputed company. With more than 1100 employees, our reputed company starts from reputed company. We offer a workplace where reputed company, curiosity, and initiative reputed company, and where your role evolves with your ambition. Instead of rigid structures, we reputed company reputed company responsibility, freedom to explore, and support to grow. Together, we shape not only the reputed company of reputed company and the development of our people, but also the health of communities worldwide. Apply tot his job Apply To this Job