Product Quality Manager

5 days ago

Brisbane, Queensland, Australia beBeeQuality Full time $106,823 - $143,683
Job Description

The Brisbane site is a multi-product biopharmaceutical site with development and manufacturing facilities for biopharmaceutical products for clinical trials (Phase I, II and III) as well as commercial products.

Manufacturing of biopharmaceutical products is required to be in compliance with regulatory requirements as defined by applicable regulatory agencies.

The Quality Assurance group is responsible for ensuring compliance to the applicable cGMP requirements.

Key Responsibilities:

  • Drive compliance to the Quality Management System, by performing real time batch record reviews.
  • Review protocols during the manufacturing process as well as post production to ensure the quality of the product.
  • Perform routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.
  • Perform final QA review and approval of batch related documentation.
  • Active participant in deviation investigations.
  • QA review and approval of Process Validation / Equipment Validation documents for example Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc.
  • QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings etc.
  • Review and approval of QA controlled documents within the Quality Management System.
  • Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs).
  • Issuing protocols as required to other departments.
  • Perform quality functions including rejects, vial thaw, drug substance shipping as required.
  • Updating SOP's and other documents to meet current regulatory and corporate standards.
  • Serving as a resource to the operational areas on quality related issues.
  • Identification of continual improvement opportunities.
  • Conducting Internal Audits.
  • Participating in Risk Assessments.
Required Skills and Qualifications

Qualifications & Experience:

  • Tertiary Academic level in a relevant discipline (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).
  • Minimum 3 years of experience in a GMP regulated environment.
  • Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment.

Skills & Attributes:

  • Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.
  • Strong communication skills.
  • Strong written, verbal and presentation skills.
Benefits

EHS Policies:

  • Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment.
  • Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported.
Others

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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