PQE Group is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide.
As an international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com.
Due to a constant growth, PQE is looking for a new GMP Lead Auditor - responsible for making relevant decisions concerning the audit process and to control auditing activities, willing to support us for project activities in Singapore
RESPONSIBILITIES include, but are not limited to, the following:
- Prepares and conducts GMP/GDP audits to suppliers/contractors as guided by PQE TPA team.
- Conducts audits in accordance with PQE standard operating procedures and clients' directives.
- Evaluates and ensures that Quality Management System, Personnel, Premises, Equipment & Systems, Processes, and Documentation of suppliers/contractors are in compliance with GMP requirements.
- Escalates immediately to PQE and Clients' Management any critical compliance issues.
- Communicates audit results immediately to PQE and Clients' Management.
- Timely documents the audit through a comprehensive audit report.
- If required, manages post-audit activities by reviewing and following up on the auditee CAPA plan.
- Coaches and supervises junior auditors, if requested.
- BS/BA with 5-7+ years of related experience in Biotech/Pharmaceutical industry
- 5 years of audit experience in a GMP environment
- Fluent English (at least B2Level)
- Availability to travel domestically and abroad. This position requires approximately 50% travel.
JOB TYPE: On-demand/Freelancers
If interested, please send your resume in English, clicking on this page.
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