R&D Quality Assurance Professional

Job Description

Responsibilities:

Verification and Validation:

- Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements.
- Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines.
- Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards.

Analytical and Microbiology Methods:

- Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems.
- Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing.
- Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements

Data Review and Integrity:

- Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation.
- Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs.
- Identify and resolve any data discrepancies or deviations from established protocols.

Regulatory Compliance:

- Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations.
- Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports.

Continuous Improvement:

- Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes.
- Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs).

Training and Development:

- Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance.
- Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance

What youd gain:

- Invaluable hands-on experience working alongside seasoned developers.
- Opportunity to learn and grow in a supportive environment.
- Gain exposure to the entire software development lifecycle.
- Contribute to real-world software projects and make a positive impact.

Qualifications:

- Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required.
- Advanced degree (Masters or Ph.D.) in a related field is preferred.
- Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries.
- Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing.
- Strong expertise in analytical and microbiological methods and their application in product development.
- Excellent attention to detail and analytical skills with a focus on data integrity and accuracy.
- Strong written and verbal communication skills, with the ability to document and present complex technical information clearly.
- Ability to work effectively in a team-oriented environment and collaborate across multiple departments.
- Proficiency with quality management systems and software tools.
- This position is remote and may require occasional travel to other sites or meetings.
- The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

---