Hozzászólva: Egyéb itt Dél-Korea | Posted: |
PQE Group is a Contract Quality Organisation and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turn key quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
Due to a constant growth, PQE is looking for a new Pharmacovigilance Auditor - responsible for conducting PV audits to suppliers/contractors, within designated Quality Auditing areas and willing to support us for project activities in South Korea.
Responsabilities include, but are not limited to, the following:
- Preparing and conducting GVP audits to suppliers/contractors
- Conducting audits in accordance with PQE standard operating procedures and clients' directives
- 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
- Degree in Life Sciences
- At least 3 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organization
- Audit and /or QA experience is mandatory
- Knowledge of GVP regulation as well as 21 CFR and other applicable regulations
- Excellent knowledge of and experience with pertaining international and local PV legislation, guidelines and directives and able to assess the impact of changes in your areas of expertise
- Availability to travel domestically and abroad (at least 50%
- Excellent use of major productivity SW (e.g.: MS Office)
- Good communication and interpersonal skills
- Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work
Languages: Fluent English (at least B2/C1 Level) both in speaking and in writing. Any knowledge of a second language would be considered as plus
Location: South Korea
Job type: On-demand/Freelancer
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.