Clinical (GCP) Quality Assurance Manager

BBBH33982_1706665930
  • Melbourne, Victoria
  • Permanent

Sydney NSW

Pharmaceuticals & Medical Devices (Healthcare & Medical)

Full time

ROLE/DESCRIPTION

  • supporting the Quality and Regulatory Head with duties related to all things GCP compliance for clients
  • working closely with other departments of the company directing and collaborating with them on all things quality compliance
  • Investigate non-conformance issues
  • Host or co-host Audits
  • Line management to one currently, will change over time
  • Training of GCP compliance
  • Documentation / reporting
  • Driving the execution of all things clinical compliance
  • Working with senior management on some strategic direction
  • data capture and archiving

REQUIREMENTS

  • Life sciences degree
  • Clinical trials ideally early phase
  • Strong knowledge and understanding of ICH GCP and applicable local and global regulations
  • excellent spoken and written English
  • Have worked in a Clinical Quality role previously
  • Eligibility to work in Australia already

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Executive Consultant, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

Quality Associate, GCP, Quality Assurance Associate, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, QMS, CAPA, ISO 13485.

Tom Desborough Executive Consultant

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