Global Quality - Auditor lead AMEA
Sanofi Aventis
Full time- 10+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 26, 2024
- End Date: Jun 26, 2024
- 10+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 26, 2024
- End Date: Jun 26, 2024
Skills:
- pharma
- Quality control
- Management
Job Description:
Responsibilities
- Manage a team of auditors located in Hyderabad (India) and coordinate the activity.
- Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers) mainly in AMEA (Africa, Middle East, Asia) region (significant part of the time 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.
- Ensure adherence to audit metrics and internal departmental SOPs for the region.
- Ensure the effectiveness of the implementation of Sanofi/Opella Quality standards and procedures.
- 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 Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the AMEA region as required.
- Ensure the onboarding, training and certification of the Global Quality auditors in the region and globally as needed.
- Provide expertise on GxP requirements to the entities in the AMEA region.
- Organize communications / meetings / Training with the Quality network in the AMEA region as necessary.
Qualification & Experience
- Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.
- Pharmacist or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields
- Excellent knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Neutraceutical, Cosmetics, Medical Devices)
- Be a qualified auditor, minimum experience of 10 years in a GMP/GDP environment.
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Salary
Not Disclosed
-
Role
Executive or Officer
-
Area of Practice
- Quality Assurance/ Quality Control
-
Experience
10+ years
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