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Lead Quality Assurance Engineer
2 months ago
At Novartis, we are dedicated to pioneering advancements in nuclear medicine and providing innovative targeted radioligand therapy (RLT) solutions for cancer patients. We seek a seasoned professional from the pharmaceutical sector with expertise in validation, maintenance, engineering, or quality assurance to become a vital part of our team at the new Lutetium isotope production facility.
Key Responsibilities:
Phase One: Greenfield Project
- Serve as the primary QA liaison and subject matter expert during the design, construction, commissioning, qualification, and validation of manufacturing and quality control areas.
- Participate in cross-functional project teams, representing the quality function in commissioning activities such as Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Collaborate with the Manufacturing Science and Technology department to review and endorse the qualification and validation master plans for the expansion project.
- Ensure the integration of Novartis and regulatory requirements into the commissioning, qualification, and validation protocols.
- Assist in the creation and review of documentation for regulatory submissions and support pre-approval inspections by health authorities.
- Facilitate the expansion of the site with additional manufacturing lines, including the establishment and approval of maintenance and calibration strategies, validation protocols, and records for production and quality control.
- Act as the primary QA contact during audits and inspections, providing expertise in GMP regulatory compliance, particularly concerning qualification.
- Investigate deviations related to validation, maintenance, and technical production issues, ensuring thorough root cause analysis and timely corrective actions.
- Review and approve changes to facilities, computerized systems, and production equipment, ensuring alignment with corporate procedures.
- Contribute to the Annual Product Review documentation.
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- A minimum of 5 years of experience in validation, maintenance, engineering, or quality assurance within a pharmaceutical cGMP or medical device environment.
- Comprehensive knowledge of cGMP regulations.
- Strong collaboration and communication skills.
- Proficient administrative skills with a working knowledge of MS365 and Adobe Acrobat.
The expected salary range for this position is between $112,800 and $169,200 annually, with potential adjustments based on market conditions and individual qualifications. The total compensation package may include various elements such as bonuses, stock options, and a comprehensive benefits package.
Diversity and Inclusion Commitment:
Novartis is committed to fostering an inclusive workplace that reflects the diversity of the communities we serve. We encourage applications from all qualified individuals.
Accessibility and Accommodations:
We are dedicated to providing reasonable accommodations for individuals with disabilities throughout the application process.
