| Job Description | Details |
|---|---|
| Company Name | Novartis Healthcare Private Limited |
| Post Name | Senior GCP/PV Auditor |
| Employment Type | Regular, Full time |
| Job Location | Mumbai, India |
| Expected CTC | Not specified |
| Vacancy | Not specified |
| Starting Date of Online Application | June 27, 2024 |
| Last Date of Online Application | Not specified |
Summary:
Lead, support, and report independent GCP/PV audits according to the Novartis Quality Systems and current GCP/PV regulations to assess compliance with applicable standards and guidance. Provide consultation through risk-based assessments and act as Subject Matter Expert (SME).
About the Role:
Lead, support, and report independent GCP/PV audits. Review and approve corrective action plans, ensuring alignment with strategic directions. Provide technical guidance, mentorship, and training. Actively participate in compliance initiatives and support inspection readiness.
Key Responsibilities:
- Develop global audit strategy and plan.
- Lead, plan, conduct, document, and follow-up on audits.
- Provide technical guidance, leadership, and mentoring.
- Ensure escalation of critical findings and support follow-up actions.
- Identify quality and compliance issues, recommend remediations.
- Support mock pre-approval inspections (PAIs) and health authority inspections.
- Stay updated on global compliance initiatives.
Essential Requirements:
- 15+ years of GCP/GPvP/clinical/industry experience.
- 8+ years of GCP/PV auditing experience preferred.
- Ability to lead and evaluate compliance issues objectively.
- Experience with Health Authority inspections preferred.
- Excellent communication and organizational skills.
- Extensive knowledge of GCP, PV, and GxP regulations.
Desirable Requirements:
- Graduate in natural/biological sciences or equivalent.
Why Novartis:
Novartis aims to reimagine medicine to improve lives and strives to become the most valued medicines company globally. They offer comprehensive benefits and opportunities for career growth.
This table summarizes the Senior GCP/PV Auditor position at Novartis Healthcare Private Limited in Mumbai, highlighting key responsibilities, qualifications, and insights about working at Novartis.
Important Notice and Disclaimer:- CareerBoostZone platform is a free Job Sharing platform for all the Job seekers. We don’t charge any cost and service fee for any job which is posted on our website, neither we have authorized anyone to do the same. Most of the jobs posted over Seekajob are taken from the career pages of the organizations. Jobseekers/Applicants are advised to check all the details when they apply for the job to avoid any inconvenience.
