Posted on: September 15, 2018
Responsible for the quality audits in Regulatory Affairs (RA) , Pharmacovigilance (PV) R&D clinical (GCP), and/or non-clinical (GLP), areas to ensure systems, procedures and resources are in place for effective implementation of the Lilly Quality Standards (LQS) and the Elanco Quality Standards (EQS). The scope of this role covers R&D, RA and PV audit activities
Functions, Duties, Task:
- Execute risk based EGQCA audit program and strategies and identify non-compliance issues to minimize any potential compliance risks which could result in delays in application approvals and/or adverse regulatory impact.
- Plan, coordinate, manage, support and/or lead audits according to the approved EGQCA audit plan in R&D, RA and PV areas in accordance with EGQCA audit programs, strategy and priorities.
- Apply a risk-based audit approach for the identification of audit targets with the objective to optimize value, time and resources while minimizing business risks.
- Perform quality assessments such as due diligence and/or pre-qualifications of Contract Research Organization (CRO), investigator sites, laboratories, third parties and suppliers for GCP, GLP, RA and/or PV activities.
- Conduct routine systems audits of Elanco affiliates and R&D sites, directed/for cause audits of focused specialized areas, mock audits (as part of the regulatory inspection readiness, preparation for pre-submission/pre-approval inspections) according to the requirements laid down in the relevant LQS/ EQS and the site specific Standard Operating Procedures (SOP) .
- Prepare and issue quality assessments and/or audit reports; assess adequacy of the auditee's responses to audit observations/findings and approve Corrective Action and Preventive Action (CAPA) plan.
- Ensure appropriate notification to management in case of critical observation/finding and support immediate follow-up measures according to EQS.
- Act as Subject Matter Expert (SME), as assigned by EGQCA management by providing sound guidance to Elanco associates, customers and management, where appropriate.
- Support in the preparation of regulatory authority inspections to ensure Elanco affiliates/sites are prepared and supported for any regulatory inspection readiness.
- Ensure proper management, follow-up and closure of audits as well as regular monthly reporting of key quality indicators (KQIs) associated with audits, tracking and completion of CAPAs in TrackWise (TW138) audit database.
- Communicate and liaise with internal and external stakeholders to drive quality mindset
Key Performance Indicators
- Completion of assigned audits in line with the approved annual audit plan.
- Reporting of all performed audits within established timeframes.
- Efficiency and effectiveness of auditing activities.
- Technical knowledge in Pharmacovigilance
- Experience in Regulatory Affairs
- Knowledge of Compliance and Industry Standards in GCP, GLP and PV.
- Technical knowledge of preclinical and/or clinical drug development
- Excellent negotiation and interpersonal skills
- Ability to communicate effectively (written & verbal)
- Flexibility to work additional hours, as needed
- Ability to undertake local, interstate & international business travels.
- Knowledge of other languages applicable to the region.
- This role can be located remote employee as long as near an international airport
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
- Bachelor degree in Science (agriculture, biology or chemistry) or related field (e.g. veterinary
- 5 years of clinical/industry/health authority experience in regulated industry;
- 1 years Quality Assurance auditing experience
- Fluency in English is essential.
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
State / Province
Keywords: Elanco, Indianapolis , Auditor-Quality-R&D\/Regulatory, Accounting, Auditing , Indianapolis, Indiana
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