Overview
Manager – Quality Services (Third Party Audits) Jobs in Chengdu, Sichuan, China at 山东赛诺菲电子科技有限公司
Title: Manager – Quality Services (Third Party Audits)
Company: 山东赛诺菲电子科技有限公司
Location: Chengdu, Sichuan, China
该职位来源于猎聘 Third Party Audit Team comprises of 8 members and are part of M&S Services department. Purpose: To perform GxP Quality Audits of all Third Parties (Pharmaceuticals Starting Materials. APIs, Excipients, Packaging materials, Drug Product Manufacturers, Service Providers, Medical Devices, etc.) located in India and Asian countries, requested according to annual plan, on behalf of Sanofi entities. Mission:
- Provide an accurate, independent assessment of suppliers and contractors used by Sanofi sites.
- Ensure that Third Parties achieve, maintain and improve the expected level of quality
- Organize, Plan & Perform Quality Audits of Third Parties, upon request according to annual audit program in place.
- Provide an independent assessment of Third Parties quality in place with regards to material compliance, as well as regulatory and quality requirements.
- Identify gaps and area of improvements, communicate results if needed and ensure the availability of CAPA for complete communication.
- Interface between the Third Parties and sites using them to facilitate follow up of improvements and exchange of quality information.
- Participate in qualification of new auditors in the hub, by performing audits with them and providing expertise regarding quality assessment of Third Parties.
- Support audits led by other auditors when specific expertise is needed (e.g. for cause audit with user site representative, highly sophisticated topics).
- Interact with Global Quality Third Parties Audit Management and Third Parties Quality Management colleagues for enhancement as & when required.
- Propose innovative solution to improve Third Parties Quality Audit process as & when required.
- Participate to Quality Documentation update as & when required.
- Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organizations (CMO), TPM/CMO Operations, Affiliates, and other Stakeholders.
- Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets.
- Ensure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / or issues relating to product design, manufacturing quality programs and product start-ups at TPM’s and CMO’s.
- Support Root Cause Analysis (RCA) investigations of quality events as required
- Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues.
- Lead the Quality Compliance team ensuring cGMP compliance and inspection readiness.
- Manage supplier audit programs and follow-up on regulatory audits.
- Oversee Regulatory Intelligence and contribute to Quality Risk Management (GRT) on-site.
- Identify and propose process and procedure improvement proposals.
- Manage supplier audits, ensuring cGMP and SOP alignment.
- Track market developments, regulatory changes.
- Contribute to team effectiveness, identify risks, formulate improvements.
- Manage work processes efficiently, respect laws.
- Follow up on CAPA’s.
- Proactively monitor FDA, EMA requirements, share knowledge.
- Coach and direct the team, conduct evaluation interviews, and assess training needs.
- Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites
- Being a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate exchange of quality information
- Support audits lead by other auditors when specific expertise is needed (e.g. for cause audit with user sites representatives, highly sophisticated topic)
- Organize day to day agenda according to workload defined by the group. Establish monthly reports and indicators for priority decisions.
- Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies.
- Prioritize audit planning to meet audit, assessment, and monitoring plans.
- Collaborate with stakeholders regionally for inspection preparedness.
- Minimum 7 years’ experience in Quality and/or Regulatory function at reputed Pharmaceutical / Biopharmaceutical Company with experience in performing Third Party Audits in various categories including API, Excipients, Chemicals, Raw Materials, Drug Product Manufacturers, Service Providers, etc.
- Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics
- Should be knowledgeable in Quality functions of pharmaceutical industry.
- Experience in conducting on site audits, inspections and facing regulatory/health authority inspections/audits.
- Thorough knowledge of CAPA systems is required and experience is desirable
- Thorough knowledge of and experience in application of GMP requirements
- Experience managing third party manufacturers and/or contract
