
Senior GCP/PV Auditor
2 days ago
- Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
- Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence.
- Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities. Prepare audit reports, according to NVS requirements and timelines.
- 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. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)
- Identify and communicate quality and regulatory compliance issues to quality management through appropriate channels as well as recommend remediations. Lead compliance investigations and initiatives focused on inspection readiness and quality, process, and compliance improvement as requested.
- Support mock pre-approval inspections (PAIs) and HA inspections as needed. Proactively research local and global initiatives, trends, and events that impact the maintenance of compliance. Mentor GCP/PV staff as required. Complete any other request from global GCP Audit. Review and approve audit reports as required and also participate in the Lead Auditor program.
- Essential Requirements:15+ years of proven experience inGCP / GPvP / clinical / industry / healthauthority experience or equivalent.
- 8+ 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.
- Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. Good knowledge of CSV and 21 CFR Part 11, ability to lead audit teams, and operate successfully in various team capacities.
- Excellent leadership and facilitation skills, Auditor certification desirable.
-
Senior Compliance Auditor
2 days ago
Mumbai, Maharashtra, India beBeeAuditor Full timeJob SummaryThis is a critical leadership role that requires exceptional experience in GCP/PV auditing, regulatory compliance, and quality management. The ideal candidate will have a strong track record of leading global audits, conducting thorough risk assessments, and providing technical guidance to team members.About the RoleLead the development of a...
-
Global Audit Strategist
2 days ago
Mumbai, Maharashtra, India beBeeAudit Full time ₹ 17,50,000 - ₹ 21,80,000Job OpportunityThe Senior GCP/PV Auditor will play a key role in developing and implementing a global risk-based audit strategy.Key ResponsibilitiesLead the planning, execution, documentation, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP.Provide expert guidance and training to other auditors on audit-related...
-
Global Compliance Assurance Leader
2 days ago
Mumbai, Maharashtra, India beBeeAuditor Full timeSenior GCP/PV Auditor Job DescriptionThis is a senior-level position responsible for leading and conducting global quality regulatory compliance audits and assessments of GCP/GPvP.The ideal candidate will have extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. They will also have excellent leadership and...
-
Manager, Pv Safety System
4 weeks ago
Mumbai, Maharashtra, India Johnson & Johnson Full timeAt Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across...
-
Manager_Branch Auditor
4 weeks ago
Mumbai, Maharashtra, India Skillventory Full timeJob DescriptionThe role of the Internal Auditor is to conduct an independent and objective assessment of the processesand provide an unbiased opinion of the Companys operations. Auditor needs to evaluate and improvethe effectiveness of the control, risk management, and compliance processes.INAs scope of work as the Third Line of defence includes:- All PCHFLs...
-
Infocepts - GCP Architect
4 weeks ago
Mumbai, Maharashtra, India InfoCepts Technologies Pvt. Ltd. Full timePosition : GCP Architect (Data Engineering)Key Result Areas :- Architect modern D&A solutions using best of breed cloud services specifically from GCP aligned to client needs and drive implementation for successful delivery.- Demonstrate expertise for client success through delivery support and thought leadership cloud data architecture with focus on GCP...
-
Senior Internal Auditor
1 week ago
Mumbai, Maharashtra, India Russell Investments Full time US$ 90,000 - US$ 1,20,000 per yearBusiness Unit:Compliance, Risk and Internal AuditReporting To:Associate Manager, Internal AuditShift:EMEA (1:30 pm - 10:30 pm IST) (India)About Russell Investments, Mumbai: Russell Investments is a leading outsourced financial partner and global investment solutions firm providing a wide range of investment capabilities to institutional investors,...
-
Senior Financial Risk Auditor
9 hours ago
Navi Mumbai, Maharashtra, India beBeeRisk Full time ₹ 4,80,000 - ₹ 6,00,000Job Role: Financial Risk AuditorJob Overview:We seek a meticulous and skilled Senior Auditor to ensure financial accuracy, compliance, and operational efficiency.This dual-role position requires strong statutory auditing procedures and core accounting functions. The ideal candidate will be a qualified CA Inter/CMA Inter or a graduate with substantial...
-
Lead Presales GCP Solution Architect
4 days ago
Mumbai, Maharashtra, India Capgemini Full timeJob Title: Lead Presales GCP Solution ArchitectExperience: 15+ yearsLocation: Mumbai/Bangalore/Hyderabad/ChennaiRole Overview:We are looking for a visionary Lead Presales GCP Solution Architect with deep expertise in enterprise cloud architecture and presales leadership. This role demands a strategic thinker who can engage with CXOs, shape large-scale...
-
Gcp data engineer
22 hours ago
Mumbai, Maharashtra, India VSquare Systems Pvt. Ltd. Full timeJob Title: Data Engineer – GCP, ETL & InformaticaLocation: Pune (Hybrid Work Model)Experience: 3–6 YearsJob Type: Full-Time | Immediate Joiners OnlyCompany: Vsquare Systems Pvt. Ltd.About Vsquare Systems Pvt. Ltd.Vsquare Systems is a technology-driven organization delivering cutting-edge IT and data solutions to a global clientele. Our culture emphasizes...