Quality Control Manager
Aegros Therapeutics Pty Ltd, Australia
Job Description
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collected into life saving hyperimmune products.
It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisen for a Quality Control Manager to join our team. Reporting to the Chief RAQA, you will be responsible for reviewing and approving specifications, testing data and things that affect the quality of the finished product to ensure no errors along with the final product itself.
In this role you will be instrumental in leading the Quality Control team ensuringconformance to GLPand that the highest standard of quality is maintainedas we embark on our journey of qualifying our equipment in our newly build laboratories.
The role will require to manage and lead a growing team.
What you will be involved in
• Perform full spectrum of QC function.
• Set-up and maintain QC laboratory.
• Ensure QC and operational compliance with regulatory requirements.
• Lead for key QC systems such as testing, release of raw materials and finished products, etc.
• Support QA amp; RA activities.
• Lead in developing and implementing quality strategies and key reporting metrics.
• Evaluates production capabilities and recommend improvements.
• Provide technical assessment and serve as subject matter subject.
• Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New product introduction and Documentation Control to ensure an efficient operational QC system that assures full compliance with company policies, regulatory requirement and cGMP
• Responsible for ensuring that product to be released meets specification and regulatory requirements
• Responsible for providing quality control oversight for Operations activities
• Raise OOS and lead the investigations.
• Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
• Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with TGA and other regulatory agencies as necessary.
• Establishing appropriate controls for the QC Laboratory.
• Provide support/guidance for the implementation and maintenance of corporate and cGMP standards.
• Perform all duties necessary to confirm compliance with local regulatory and company requirements.
Requirements
What we would expect from you:
• Perform full spectrum of QC function.
• Set-up and maintain QC laboratory.
• Ensure QC and operational compliance with regulatory requirements.
• Lead for key QC systems such as testing, release of raw materials and finished products, etc.
• Support QA amp; RA activities.
• Lead in developing and implementing quality strategies and key reporting metrics.
• Evaluates production capabilities and recommend improvements.
• Provide technical assessment and serve as subject matter subject.
• Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New product introduction and Documentation Control to ensure an efficient operational QC system that assures full compliance with company policies, regulatory requirement and cGMP
• Responsible for ensuring that product to be released meets specification and regulatory requirements
• Responsible for providing quality control oversight for Operations activities
• Raise OOS and lead the investigations.
• Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
• Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with TGA and other regulatory agencies as necessary.
• Establishing appropriate controls for the QC Laboratory.
• Provide support/guidance for the implementation and maintenance of corporate and cGMP standards.
• Perform all duties necess