Validation Contractor

7 months ago

Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

Aegros Therapeutics Pty Ltd is looking for a Validation Contractor to join our team. As a Validation Contractor, you will play a crucial role in ensuring the quality and effectiveness of our therapeutic plasma products. Aegros is dedicated to transforming the lives of patients by providing a safe, secure, and sustainable supply of therapeutic plasma products. We believe that access to these life-saving drugs is a human right, and we strive to place the patient first in everything we do.

As a Validation Contractor, you will be responsible for contributing to the validation and qualification of processes, equipment, and systems in compliance with regulatory requirements. You will help establish robust and efficient processes, ensuring the quality and reliability of our products. This role requires strong attention to detail and the ability to analyze and interpret complex data.

Aegros Therapeutics is an innovative company with a passion for making a difference in patients' lives. By joining our team, you will have the opportunity to contribute to our mission and work with a dedicated group of professionals.

**Responsibilities**:

- Assist in the development and execution of validation protocols and reports for equipment, processes, and systems.
- Conduct risk assessments and analysis to identify potential validation issues and develop mitigation strategies.
- Perform validation testing and data analysis to ensure compliance with regulatory standards.
- Collaborate with cross-functional teams to ensure alignment and adherence to validation requirements.
- Assist in the development and implementation of validation methodologies and strategies.
- Provide input and recommendations for process and system improvements.
- Stay up-to-date with industry trends and best practices in validation and compliance.

**Requirements**:

- Bachelor's degree in a relevant scientific discipline.
- Minimum of 3 years of experience in validation, preferably in the pharmaceutical or biotechnology industry.
- Strong knowledge of regulatory requirements and guidelines, such as FDA, EMA, and GMP.
- Experience with process validation, equipment qualification, and cleaning validation.
- Proficient in data analysis using statistical software.
- Strong attention to detail and analytical thinking.
- Excellent communication and teamwork skills.
- Ability to prioritize and manage multiple projects simultaneously.

**Benefits**
- Close to public transport, cafes and Macquarie Centre
- Working for an innovative Biopharmaceutical company with huge growth potential
- We celebrate having a diverse workforce
- Working holiday visa applicants welcome

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