GMP Compliance Specialist

About the company

This business is a leading TGA/GMP-licensed pharmaceutical company with a strong presence in both Australian and global markets. We manufacture and supply high-quality products and radiopharmaceuticals supporting Nuclear Medicine, Oncology, and specialised contract manufacturing services. We play a key role in advancing patient care and medical diagnostics.

Your new role

Reporting to the Quality Assurance Manager you will be working in the Radpharm Scientific Quality Department.

What you will get in return

·       Career development opportunities

·       Flexibility/Work life balance

·       Supportive senior and executive management

·       Team building activities/social events

·       Birthday Day off

Duties

• Assess updates to regulations and standards for impact on the Company's QMS, Products, and Operations.
• In conjunction with National personnel, the Regulatory Affairs Manager, and QA Manager, ensure that all TGA product registrations, licences and certificates are current.
• Prepare and/or review quality system documentation including SOPs, WIs, Laboratory Worksheets, Specifications, Batch Manufacturing Records, etc
• Conduct periodic product reviews, and investigations into deviations/complaints/recalls, laboratory investigations, and other quality events.
• Maintain qualified investigator and lead internal auditor qualifications, and Authorised Person status.
• Collate and analyse quality and compliance system information and data for effective trending purposes including presentation to Senior Management.
• Facilitate the operation of site QMS systems by:

Completion of system effectiveness reviews and trending

Supporting and/or leading meetings relating to quality systems (e.g. Change Control Committees, Due Date Extension Committees).

• Assist with the auditing program:

Prepare and lead internal audits as per the schedule

Prepare, review and approve internal audit reports

Manage closeout activities following internal and external audits

Assist in the preparations for external and regulatory audits

Act as a quality and compliance subject matter expert during internal, external, and regulatory audits

Perform external audits of suppliers and contractors as required.

• Support and drive a continuous improvement quality culture.
• Act as a delegate for the QA Manager when required.

What you will need to succeed

·       Highly organised

·       Able to engage and communicate effectively with a range of stakeholders

· years' experience in GMP Quality Assurance or Regulatory Affairs within the health care industry

·       Attention to detail and critical thinking

·       High proficiency in writing and reviewing procedural and technical documents

·       Problem Solving oriented

·       Bachelor's degree in Science or Pharmaceutical field

·       Sterile manufacturing/testing experience

·       TGA/GMP regulatory knowledge