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GMP Clearance Associate

GMP Clearance Associate

ProductLife GroupThane, IN
10 days ago
Job description

Role Description :

The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality, and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of GMP Clearance applications as well as a range of compliance documents or related quality activities. The Associate Consultant also supports the delivery of a variety of projects, working closely with the Regulatory, Quality & Compliance Administrators, Associates, Associate Consultants, Consultants, Senior Consultants, Manager, Senior Manager, and / or Head of Business Unit to deliver a superior client experience and optimize project outcomes.

Role Responsibilities :

General :

  • Adherence to ProductLife Group's values, policies, and quality management systems.
  • Perform compliance activities to meet ProductLife Group and client Quality objectives.
  • Support audit requests as required.
  • Manage and prepare GMP clearance applications for submission to the TGA and / or other regulatory agencies, as required.
  • Provide regulatory, quality, and compliance support to clients relating to the registration / listing of pharmaceuticals, biologicals, and medical devices and the ongoing maintenance of these.
  • Assist clients in responding to agency questions.
  • Provide support to clients by assisting more senior members of the team with regulatory, quality, and compliance activities.
  • Prepare, review, and update quality documentation.
  • Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.

Qualifications / Experience / Skills :

  • Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.
  • A minimum of 3 years of experience in Australian and New Zealand Quality or Regulatory Affairs, preferably in a commercial environment.
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures is preferable.
  • Reasonable computer literacy.
  • Proven experience dealing with a high level of confidentiality.
  • Good problem-solving and project management skills.
  • Ability to work to deadlines.
  • Attention to detail.
  • Excellent written and spoken communication and interpersonal skills.
  • Interest in the practice of consulting.
  • An appetite for learning and development.