QC Team Leader
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 Team Leader to join our Quality Compliance team. In this role you will oversee the daily activities of the Chemistry department while leading and mentoring a team of Senior Chemists and QC Chemists to achieve and monitor KPIs and targets for Chemistry to ensure the successful operations in accordance with the Aegros Quality Systems.
What you will be involved in
- Managing the Quality Control Chemistry Laboratory team, including planning of activities and resources, execution of analysis, reporting of results, and reporting of key performance indicators
- Assisting the QC Manager in establishing the goals and objectives of the team, ensuring a high level of analytical quality
- Support the QC team for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines
- Support the QC Team on equipment maintenance and calibration.
- Conducting peer review and technical review of analyses for completeness and cGMP compliance
- Ensuring the effectiveness of the Quality Control Chemistry Laboratory aligns with OHamp;S guidelines and Quality Standards
- Tracking and reporting milestones, ensuring efficiencies are gained
- Assisting with regulatory ,QA and other relevant team in all aspects of the QC Chemistry Team
- Implementing Quality Control tasks such as Change Controls, Deviations, CAPA, OOS/OOT, and Documentation Management
- Undertaking internal audits as per the requirement
- Assisting with the training of team members as required
- Implementing workplace learning by setting team member training and performance goals, ensure team members are trained, competent, performance reviewed (yearly) and supported in their career development.
- Performing any other duties assigned by manager or delegates.
- Flexible to work is shifts across the day on a rotating roster.
Requirements
What we would expect from you:
- A Bachelor of Science degree or equivalent
- A minimum of 5-8 years’ experience in microbiological testing and analysis in QC laboratory as an analyst in pharmaceutical or equivalent industry
- Prior leadership experience is highly desirable
- Expertise within technical writing skills and record keeping
- Excellent knowledge of Microsoft office including word, excel ,PowerPoint etc
- An understanding and experience of quality systems and the need to develop and follow SOPs, particularly in a cGMP environment
- Good verbal and written communication skills;
- Protein chemistry and associated analytical biological assays but not essential
- Knowledge of biological separation technologies and processes but not essential
- Knowledge of relevant regulatory requirements (FDA, EMA or TGA).
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...!