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Medical Affairs Specialist | Sydney based
• Sydney
• Pharmaceutical / Medical
• Sydney
• Pharmaceutical / Medical
Be part of a collaborative team working in a niche specialty care company, who's building a great team to work on pipeline products...
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Quality Assurance Manager, Aegros Membrane Systems
Aegros Therapeutics Pty Ltd | Macquarie Park | Full-time | apply.workable.com |
About Aegros
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 Manager to join the Aegros Membrane Systems business. Reporting to the Head of Quality Control Unit you will lead and manage the quality management systems ensuring compliance to regulatory requirements for Aegros Membrane Systems.
With prior working experience across ISO 9001, you will work on the full spectrum of QA functions covering deviation and compliance management, products and materials release, validation and change control support, new production introduction and documentation controls to ensure an efficient operational Quality System that assure full compliance with company policies, and regulatory requirements.
Requirements
• Setting up and maintaining the QMS
• Leading for key QMS systems such as audits, CAPA, SOP review, etc
• Supporting regulatory affair activities as required
• Developing and implementing quality strategies
• Evaluating production capabilities and recommending improvements
• Providing technical assessment and serving as a quality subject matter subject
• Ensuring that materials supplied are fit for purpose for customer
• Providing quality oversight for operations activities
• Ensuring the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
• Ensuring inspection readiness of the area with respect to all internal and external audits
• Providing responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections,
• Communicating with ISO, TGA, FDA and other regulatory agencies concerned if necessary
• Providing support/guidance for the implementation and maintenance of corporate and regulatory standards.
Requirements
You will bring...
• Tertiary education in Life Sciences, Chemistry, Microbiology or related fields
• 4-8 years’ experience in managing and conducting Quality Assurance / Quality Management System functions within Pharmaceutical / Biopharmaceutical industry
• Prior experience with ISO 9001 is mandatory to have
• Experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant is desirable
• Professional membership with Quality Assurance organization is beneficial
• Excellent communication skills in English, verbally and written skills
• Strong attention to detail with a collaborative approach to work.
Benefits
Here’s what we can offer you…
• An environment which allows the individual to grow alongside the company
• A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
• The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
• A multicultural environment where every voice is heard
• Competitive remuneration package which includes an annual Bonus + Employee Share Options
• Close to public transport
Interested? Apply today...!!!!
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 Manager to join the Aegros Membrane Systems business. Reporting to the Head of Quality Control Unit you will lead and manage the quality management systems ensuring compliance to regulatory requirements for Aegros Membrane Systems.
With prior working experience across ISO 9001, you will work on the full spectrum of QA functions covering deviation and compliance management, products and materials release, validation and change control support, new production introduction and documentation controls to ensure an efficient operational Quality System that assure full compliance with company policies, and regulatory requirements.
Requirements
• Setting up and maintaining the QMS
• Leading for key QMS systems such as audits, CAPA, SOP review, etc
• Supporting regulatory affair activities as required
• Developing and implementing quality strategies
• Evaluating production capabilities and recommending improvements
• Providing technical assessment and serving as a quality subject matter subject
• Ensuring that materials supplied are fit for purpose for customer
• Providing quality oversight for operations activities
• Ensuring the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
• Ensuring inspection readiness of the area with respect to all internal and external audits
• Providing responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections,
• Communicating with ISO, TGA, FDA and other regulatory agencies concerned if necessary
• Providing support/guidance for the implementation and maintenance of corporate and regulatory standards.
Requirements
You will bring...
• Tertiary education in Life Sciences, Chemistry, Microbiology or related fields
• 4-8 years’ experience in managing and conducting Quality Assurance / Quality Management System functions within Pharmaceutical / Biopharmaceutical industry
• Prior experience with ISO 9001 is mandatory to have
• Experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant is desirable
• Professional membership with Quality Assurance organization is beneficial
• Excellent communication skills in English, verbally and written skills
• Strong attention to detail with a collaborative approach to work.
Benefits
Here’s what we can offer you…
• An environment which allows the individual to grow alongside the company
• A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
• The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
• A multicultural environment where every voice is heard
• Competitive remuneration package which includes an annual Bonus + Employee Share Options
• Close to public transport
Interested? Apply today...!!!!
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