QA Stability Specialist

2 weeks ago

Melbourne, Victoria, Australia Bayside Group Full time
  • Global Pharmaceutical Company
  • Contract Opportunity - start ASAP
  • Inner Melbourne Location
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries.

An opportunity has become available for a QA Stability Specialist who will operate as a Quality professional, focussing on the follow – up of stability studies and provide expert technical advice on Annual Stability Programs.

Your key responsibilities will be:
  • Contribute to the completion of projects, according to agreed targets and develop plans for work activities on own projects within a team.
  • Provide technical expertise in the management of stability studies, including relevant documentation, in line with current regulations, internal procedures and business needs
  • Facilitate creating and maintaining the schedule for completion of the Annual Stability Program
  • Participate in cross functional teams as required to provide support on stability report issues and assistance with investigations for out of specification or questionable investigations
  • Issue of stability studies documents (i.e. protocols, reports)
  • Ensure compliance with cGMP, corporate standards/Company's procedures (SOP's), regulatory requirements and industry standards
  • Statistical evaluation of Stability Data
About you:
  • Minimum of BSc in Chemistry or related field
  • 5+ years of appropriate professional experience preferably in a similar position (Stability Specialist) or in QA / Technical Services and / or Manufacturing areas
  • Demonstrated knowledge of Stability Program requirements
  • Outstanding verbal, written and technical communication skills
  • Excellent organisational skills with the ability to work under pressure
  • Possess strong interpersonal and leadership skills
  • Sound computer literacy with knowledge in MS Office / Business applications
  • A strong background in software such as LIMS (LabWare) and statistical software would be an advantage.
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on0437 853 201.
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