Lead Quality Assurance Engineer
3 weeks ago
At Novartis, we are at the forefront of innovation in nuclear medicine, dedicated to advancing targeted radioligand therapy (RLT) for cancer patients. We seek a seasoned professional from the pharmaceutical sector with expertise in validation, maintenance, engineering, or quality assurance to contribute to our new Lutetium isotope manufacturing facility.
Role Responsibilities
Initial Phase: Greenfield Project
- Serve as the QA liaison and subject matter expert for the design, construction, commissioning, qualification, and validation of manufacturing and quality control areas.
- Represent the quality department in cross-functional project teams and during commissioning activities such as Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Collaborate with the Manufacturing Science and Technology (MS&T) department to review and endorse the qualification and validation master plans for the expansion project.
- Act as a key resource for integrating Novartis and regulatory requirements into commissioning, qualification, and validation protocols.
- Assist in the creation and evaluation of documentation for regulatory submissions and support pre-approval inspections by health authorities.
- Facilitate the site's expansion with additional manufacturing lines, including the establishment and approval of maintenance and calibration strategies, validation protocols, and records for production and quality control.
- Serve as the primary QA contact for validation, calibration, and maintenance during audits and inspections, with a focus on Good Manufacturing Practice (GMP) regulatory compliance.
- Conduct investigations into deviations related to validation and maintenance, ensuring root cause analysis and impact assessment on product quality.
- Review and authorize changes concerning the facility and production equipment, ensuring alignment with corporate procedures.
- Contribute to the Annual Product Review process.
- 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.
- In-depth knowledge of cGMP regulations.
- Strong collaboration and communication skills.
- Proficient administrative skills and familiarity with MS365 and Adobe Acrobat.
The salary range for this position is competitive and will be determined based on various factors including experience and qualifications. The total compensation package may include additional elements such as bonuses and a comprehensive benefits program.
Diversity and Inclusion Commitment
Novartis is dedicated to fostering an inclusive work environment and building diverse teams that reflect the communities we serve.
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