Aseptic Validation Specialist

**Aseptic Validation Specialist**

We are looking for an experienced Aseptic Validation Specialist, with perseverance and natural curiosity to join the Quality Assurance-Validation team:

- An exciting 12 months’ fixed term opportunity
- Facilitate stakeholder engagement with your strong service orientation

**About AstraZeneca**

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better - from patients and their families to all of us in society.

The North Ryde manufacturing facility remains an important centre for both AstraZeneca and manufacturing in Australia. We are proud of our long heritage in Australia, where for more than 65 years, AstraZeneca has been providing medicines to treat many cancers and chronic diseases, saving lives and extending life for millions of Australians.

**What you’ll do**

Reporting to the Validation Manager, the Aseptic Validation Specialist will manage projects in and provide guidance to Engineers performing validation and support their validation function.

**This role involves**:

- Write/develop/review and provide technical and compliance input to validation protocols and reports (IQ/OQ/PQ/PPQ) for Projects, Revalidation, OCM or CAPA which meet the requirements of established Testing Plans.
- Perform data analysis to evaluate process capability and make recommendations for process improvement where necessary.
- Act as an SME perform Technical approvals of OCMs.
- Coordinate project and/or production staff, activities and schedules for all assigned projects that fall in line with business objectives.
- Develop and implement work action plans to ensure projects are delivered, meeting project timelines.

**Essential for the role**
- Tertiary Qualifications in science, engineering or Quality related discipline.
- Minimum 5 years in a pharmaceutical or related industry manufacturing environment in Production, Engineering or Quality Assurance.
- Minimum 3 years in Validation.
- Attention to Detail, Analytical Thinking, Drive and Determination, Multi-Tasking.
- Test Protocol development & Report writing
- Clear and effective communication with relevant departments, Experience with working in multidisciplinary environment
- Problem Solving and conducting risk assessments.
- Good time management skills and able to work with multiple tasks and changing priorities
- Commitment and passion for Compliance and Quality, with attention to detail and ability to speak up while remaining un
- influenced.
- Leadership in areas of technical expertise.

**Desirable for the role**
- Knowledge of regulation requirements within the Pharmaceutical Manufacturing Environment
- Knowledge of Sterilisation, Cleaning, Computer and Process Validation

**Why AstraZeneca**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work

**So, what’s next?**
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have a seat available, and we hope it’s yours.

**Where can I find out more?