Location
Mumbai | India
Job description
Lead, support, and report independent GCP/PV audits according to the Novartis Quality Systems and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. Ensure alignment with the companys strategic direction and assist in driving the implementation of the applicable actions. Provide consultation to NVS business units through risk-based assessments. Act as SME for assigned areas of responsibility.
Key Responsibilities: Support the strategic development of an effective global risk-based audit strategy
Provide technical guidance and training on audit activities. Maintain current knowledge of regulations, standards, and guidance documents.
Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)
Role Requirements
Essential Requirements:
10+ years of proven experience in GCP / GPvP / clinical / industry / health authority experience or equivalent.
5+ years of GCP/PV auditing experience preferred and willingness to travel up to 60% of the time.
Ability to lead and objectively evaluate compliance issues. Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision-making and problem-solving
Experience with Health Authority inspections and interactions preferred. Good quality and compliance leadership and facilitation skills.
Excellent verbal and written communication, organizational, and interpersonal skills. Excellent computer skills including Excel, MS Office etc.
Desirable Requirements: Graduate in natural/biological sciences or equivalent, or an equivalent mix of education and experience
Job tags
Salary
