Quality Assurance Auditor II– Lucerne, Switzerland– Office Based
ClinTec International is actively recruiting for a Quality Assurance Auditor II to join our expanding global company in Switzerland on a permanent contract. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
Responsibilities of the Quality Assurance Auditor:
Work towards timelines, company and personal objectives set by Head of Clinical QA
Schedule, prepare and assist in the conduct of audits and regulatory inspections as and when required
Plan, subcontract (or conduct) audits of processes, systems, projects and/or sites within budget and established timelines
Ensure the follow-up of major and critical audit findings/Quality issues to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
Compile and prepare GCP quality metrics
Review,write and approve Audit reports and CAPAs issued by internal and external providers including assessment and follow up with individuals until closure of any CAPA.
Tracking and assessment of validation and audit status, assess with the Head of Clinical QA risks associated with each vendor and prioritize for Audit of 3rd party by external consultants or internal resources.
Ensure the Quality Assurance database and any other QA related trackers are maintained and up-to-date to reflect the status of audits being scheduled, auditor assignments and audit reporting and/or follow-up status
Follow up and drive the process for review and development of SOPs within the Development department and in conjunction with operational members of the development department
Maintain an excellent knowledge of current GXP regulations, guidelines, and related auditing techniques appropriate to work responsibilities
Provide regular feedback to the Head of Clinical QA and global Quality Management, on the above activities
QA auditor with experience in a Pharma/CRO environment and with proven track of ICH GCP knowledge and GCP QA processes and procedures
Good understanding of ICH GCP and any other QA relevant guidelines and regulations (EU and US)
Able to work independently with minimal supervision.
Good problem solving skills
Effective organization, communication, interpersonal and team orientation skills
Broad knowledge of Microsoft Office applications
Fluency in English & German (written & spoken)
Good understanding of Pharmacovigilance regulations (i.e. Guideline on good Pharmacovigilance practices) or CSV would be an asset
ClinTec International AG in Zug is a global CRO present in over 43 countries worldwide. We are currently working on strategic assignments as a pharmaceutical service provider with several major multinational pharmaceutical companies in Switzerland. As part of our expansion to our established team in Switzerland, we have a number of exciting opportunities available. By working for ClinTec you will have exposure to interesting assignments with leading players in global pharma R&D, and hence you can further your career in a dynamic, stable environment where you can be assured of rewarding benefits