Gcp/pv Auditor

2 weeks ago

Mumbai Maharashtra, India Novartis Full time

**Summary**:

- Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) -Performs preparation and management of external and corporate audits and Health Authority inspections.

**About the Role**:

- GCP/PV Auditor
- Location - Mumbai #LI Hybrid
- About the Role:

- 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 company's 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)
- 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-
Division

Operations

Business Unit

Pharmaceuticals

Location

India

Site

Mumbai (Head Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Gcp/pv Auditor

    2 days ago

    Mumbai, Maharashtra, India Novartis Full time

    392155BR **GCP/PV Auditor**: India **About the role** GCP/PV Auditor Location - Mumbai #LI Hybrid About the Role: 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...

  • Senior GCP/PV Auditor

    2 weeks ago

    Mumbai (Head Office), India Novartis Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    Job Description SummaryLead, 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 company's...

  • Senior GCP/PV Auditor

    2 weeks ago

    Mumbai (Head Office), India Novartis Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    BandLevel 5Job Description SummaryLead, 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...

  • Senior Manager-ev Finance-ev Finance-tpem

    3 days ago

    Mumbai, Maharashtra, India Tata Motors Full time

    Purpose of the Role TML PV Standalone monthly quarterly annual financial statements - interacting with all plant locations and other functions of finance including GDC Facilitating the audit and resolving queries on timely basis If no one performs the work this will result into Statutory non-compliances Companies Act non-closure of timely audit of financial...

  • Technical Manager- Audit Service Design

    2 days ago

    Mumbai, India STS Full time

    We are looking for a highly skilled Technical Manager-Audit Service Design & Delivery Expert who will lead new audit service development projects and support our Audit Service Line. This role involves designing and implementing new service offerings, managing cross-functional development activities, performing audits, reviewing audit reports, and...

  • Clinical Research Associate

    1 week ago

    Mumbai, Maharashtra, India Sun Pharmaceutical Industries Full time

    Job Title Clinical Research Associate Business Unit Clinical Research Location Hyderabad At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll...

  • It/cybersecurity Senior Auditor

    2 weeks ago

    Pune, Maharashtra, India TransUnion Full time

    What We ll Bring TransUnion works with businesses and consumers to gather analyze and deliver critical information needed to build strong economies around the world Protection of that information is critical to our customers and business As part of our 2020 transformation journey we became Global Audit Advisory GAA formerly Internal Audit As a Specialist III...

  • Clinical Research Associate

    7 days ago

    Mumbai, India SUN PHARMA Full time

    Job location: Chennai YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers...

  • Medical Reviewer

    2 weeks ago

    Mumbai, India Career Choice Solution Full time

    Mumbai Business/ Customer: - Perform medical review (including verifying the coding & labeling, reviewing seriousness, narratives, causality statement, medical aspect of followup request), validate followup request and perform medical assessment of the case as applicable. - Responsible for maintaining Medical cohesiveness of a case. - Maintaining the data...

  • Clinical Research Associate

    7 days ago

    Mumbai, India SUN PHARMA Full time

    Job Title: Clinical Research Associate Business Unit: Clinical Research Location: Hyderabad At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun...