Lead Auditor- Healthcare
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What you'll do
- Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests.
- Draft audit reports within agreed timelines.
- Management of pre-audit documents
- Preparation of the audit agenda
- Collaboration in travel preparation
- Conducting the audit
- Drafting of audit reports and audit comments. Drafting amended documents following customer request
- Evaluation of the CAPA plan
What they're looking for
- Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry)
- Technical Audit Report Writing skills are mandatory.
- Experience of minimum 10 plus years in the field of pharmaceuticals, medical devices and / or cosmetics (QA, Regulatory Affairs, QC, Consulting)
- Conducting at least 10 supplier audits and/or internal audits
- Knowledge of- EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716,CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office
- Specific technical practical skills (know-how) - Conducting Audits of Quality Management Systems
- Transversal skills- Attention to order and Quality Self-control Autonomy Analytical capacity Customer and result orientation Confidentiality Compliance with planned timelines
Nice to have
- Scientific degree preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Company Description
Eurofins Assurance India Pvt Ltd is a leading certification body providing Audit & Certification, Inspections, and other services covering the broad spectrum of sustainable supply chain.
Eurofins will help the customers to mitigate risks in their supply chain and to ensure the benchmarking performance with operations, processes, systems, people or capabilities.
Whether you are in Food, Cosmetics, Consumer products or Health care sector, our global auditor and technical expert network will help to mitigate/eliminate your risks against supply chain and distribution flows: Regulatory and Industrial standards.
We have accreditations for a number of different industry standards/memberships to ensure we service the entire supply chain.
Job Description
PURPOSE AND RESPONSIBILITIES OF THE POSITION
Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests. Draft audit reports within agreed timelines.
DESCRIPTION OF THE ACTIVITIES
Macro Areas of Activity
Pre-audit
- Management of pre-audit documents
- Preparation of the audit agenda
- Collaboration in travel preparation
Audit
- Conducting the audit
Post-audit
- Drafting of audit reports and audit comments. Drafting amended documents following customer request
- Evaluation of the CAPA plan
CROSS-FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS
Roles and Areas with which links are held
Customer
- Preparation of the audit agenda, drafting of the audit report and audit comments, make any necessary corrections and evaluation of the CAPA plan.
Supplier
- Preparation of the audit agenda, conduct of the audit
QA
- Reporting non-compliances
Finance
- Expenses reporting
Audit Sales & Planning Specialist
- Preparation of the agenda
- Collaboration for audit planning and travel preparation
Audit Sales & Planning Assistant
- Preparation of the agenda
- Collaboration for audit planning and travel preparation
Audit Customers Manager
- Collaboration in the technical review of the audit reports. Collaboration following customer requests
Audit Operations & Audit Sales Man
- Collaboration in the auditor qualification process. Reporting issues emerged during the audit
Qualifications
Educational qualification-
- Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry)
- Technical Audit Report Writing skills are mandatory.
Previous experience-
- Experience of minimum 10 plus years in the field of pharmaceuticals, medical devices and / or cosmetics (QA, Regulatory Affairs, QC, Consulting)
- Conducting at least 10 supplier audits and/or internal audits
Knowledge of- EU GMP part I & II, ISO 9001, ISO 13485, ISO 15378, ISO 22716,CFR21 part 210,211, EU GDP, IPEC guidelines, English language level C, Microsoft Office
Specific technical practical skills (know-how) - Conducting Audits of Quality Management Systems
Transversal skills-
- Attention to order and Quality Self-control
- Autonomy Analytical capacity
- Customer and result orientation Confidentiality
- Compliance with planned timelines
Additional Information
Use of equipment, utilities, software-Microsoft Office, LIMS, SAP, CDS system.
Certifications-Quality Management System, Computer System Validation, Six Sigma, ISO
Company
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