RD Quality urance

• 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.

• 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.

• 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.

• 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.

• 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).

• 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.

• Bachelor s degree in Chemistry Microbiology Biology Pharmaceutical Sciences or a related scientific discipline is required.
• Advanced degree (Master s or Ph.D.) in a related field is preferred.

• Minimum of 57 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.
• Proven track record of managing and executing method validation projects in an R&D setting.
• Experience with FDA TGA ICH and EMA regulatory requirements and guidelines.

• 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 teamoriented environment and collaborate across multiple departments.
• Proficiency with quality management systems and software tools.

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