Cmc Auditor

**Company Description** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.** **Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.**

**In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.**

**In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.**

**Responsibilities**:

- Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations
- Advise supported areas on requirements for all assigned project responsibilities as related to quality and communicate project status to management
- Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings.
- Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements
- Identify need for and/or develop SOPs to ensure practices are accurately reflected
- Represent CMC Auditing on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
- Independently prioritize activities in support of multiple projects
- Support preparations for regulatory agency inspections
- Support other functional area and departmental priorities, as needed

Lead Auditor Requirements include:

- Foster collaboration, drive results, make rapid disciplined decisions
- Demonstrate excellent organization skills
- Effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary.
- Maintain positive working relationships within CMC Auditing team and client areas
- Hold self and other accountable
- Clear communication skills (express in a clear, concise manner)
- Demonstrate interpersonal skills to effectively lead an audit
- Attend Project Team Meetings
- Act as a single point of contact
- Keep close track of submission timelines and meet deadlines while still maintaining all audit goals
- Identify and manage issues on a continuous basis (e.g. unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines)
- Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows
- Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)
- Prioritize audit sections based on CMC request
- Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues

Specific and/or additional duties may include, but are not restricted to:

- Provide tracking, trending and metrics for CMC Auditing activities
- Provide technical guidance to senior management in evaluating systems/tools
- Assist CMC Auditing staff and client areas with the technical aspects related to the use of electronic audit tools
- Support Process Improvement initiatives for CMC client and auditing area

**Qualifications**

Education Minimum Requirement:

- B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline

Required Experience and Skills:

- Minimum of 5-10 years’ experience with B.S./M.S., or five (5) years with PhD. Experience should be in pharmaceutical/biotechnology, quality or compliance role
- Extensive working knowledge of cGMPs and technical aspects of support area are required
- Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities

Previous experience required to perform job responsibilities