GMP Lead Auditor - PQE Group | New Day Jobs (Yangon, Myanmar)

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PQE Group
Remote (Asia Time Zone Permitted)

GMP Lead Auditor

Apply from Source

GMP Lead Auditor

PQE Group
  • Remote (Asia Time Zone Permitted)
  • Other
Salary : Login to view salary Apply from Source
Job Type : Contract
Education Requirement : Bachelor Degree
Skills :
Experience : 3 to 5 years
Work Days : Monday To Friday
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Job Detail

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.

REQUIREMENTS:

  • 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.

LOCATION: Singapore

JOB TYPE: On-demand/Freelancers

If interested, please send your resume in English, clicking on this page.

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.

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