Lead Auditor - QMS - Pharmaceuticals

Are you a progressive Auditor?

- Experience of 2-4 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.? If this is you, then join an energetic team of engineers building the next generation of solutions with our client.

Educational qualification : Scientific degree (preferably Pharmacy, Chemistry and Pharmaceutical Technology, Chemistry)

- Carry out audits at suppliers in accordance with reference regulations, and specific customer requests. Draft audit reports within agreed timelines

- 2-4 years of 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

Knowledge :

- 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

- 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