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Global Quality CHC – Auditor – AMEA

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Sanofi

13d ago

  • Job
    Full-time
    Senior Level
  • Legal
  • Hyderabad, +1

AI generated summary

  • You need GxP audit experience in pharma/consumer healthcare, AMEA regulations knowledge, strong communication, teamwork, time management skills, willingness to travel, and CAPA management expertise.
  • You will conduct GxP audits, prepare reports, manage CAPAs, support regulatory inspections, train auditors, and provide GxP expertise in the AMEA region. Frequent travel is required.

Requirements

  • Job title: Global Quality CHC – Auditor – AMEA
  • Location Hyderabad
  • Job type: Permanent
  • Relevant experience in conducting GxP audits in either the pharmaceutical or consumer healthcare industry.
  • Strong understanding of regulatory authority requirements in the AMEA region.
  • Excellent communication and interpersonal skills.
  • Ability to work collaboratively in a global team environment.
  • Strong organizational and time management skills.
  • Willingness to travel internationally as required.
  • Proficiency in English; additional languages are a plus.
  • Knowledge of quality management systems and audit methodologies.
  • Proven track record in managing audit corrective and preventive actions (CAPA).
  • Strong problem-solving skills and attention to detail.
  • Ability to provide training and support to auditors and stakeholders.

Responsibilities

  • Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in AMEA (Africa, Middle East, Asia) region. A significant part of the time is dedicated to international travels.
  • Support the worldwide auditor’s team as necessary.
  • Prepare audits and issue audit reports in a timely manner.
  • Conduct Global transversal assessment audits.
  • Approve / Manage audit CAPA to agreed timelines.
  • Keep up to date with current and forthcoming regulatory authority requirements, and relevant Sanofi/Opella Global Quality documents. Effectively evaluates compliance with these requirements at Opella entities and third parties and identifies ways for these entities to increase their level of compliance.
  • Together with the Audit lead & Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the AMEA region as required.
  • Support the training and certification of the Global Quality auditors in the region.
  • Provide expertise on GxP requirements to the entities in the AMEA region. Support the local auditors when specific expertise is necessary.
  • Organize communications and Training for the Quality network in the AMEA region as necessary.

FAQs

What is the location of the Global Quality CHC – Auditor – AMEA position?

The position is located in Hyderabad.

Is this position permanent?

Yes, this is a permanent position.

What are the main responsibilities of the Global Quality CHC – Auditor – AMEA?

The main responsibilities include conducting GxP audits, preparing audit reports, managing audit CAPA, supporting regulatory inspections, providing expertise on GxP requirements, and organizing training for the Quality network in the AMEA region.

Will this role require international travel?

Yes, a significant part of the time is dedicated to international travels primarily within the AMEA region.

What kind of audits will be conducted by the auditor in this role?

The auditor will conduct GxP audits at CHC sites, Development Centres, country offices, CDMOs, and suppliers of active pharmaceutical ingredients, raw materials, and packaging components.

Are there opportunities for training and certification for Global Quality auditors in this role?

Yes, the role includes support for the training and certification of Global Quality auditors in the region.

How does Sanofi prioritize diversity and inclusion in the workplace?

Sanofi provides equal opportunities to all individuals regardless of various factors such as race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

What is the overarching mission of Sanofi Consumer Healthcare?

The mission is to build a healthier future by helping people help themselves, bringing "Health in Your Hands."

What kind of compliance will the auditor evaluate at Opella entities and third parties?

The auditor will evaluate compliance with regulatory authority requirements and relevant Sanofi/Opella Global Quality documents, and identify ways for these entities to increase their level of compliance.

What type of environment does Sanofi aspire to create for its employees?

Sanofi aims to create a work environment where people can thrive, grow, and be at their best every day.

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Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.