Support the development, implementation and monitoring of Quality programs, policies, and procedures to ensure compliance with certifications/accreditations requirements, corporate policies, and procedures.
Review/approve the following:
Quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions.
Review/approval of technical and analytical documents of moderate to high complexity for reference standard development
Review/approval of change controls
Method validation reports
Equipment IQ/OQ/PQ documents
Batch Records
Lab data projects
Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a regular basis.
Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies.
Lead internal process/target audits according to a pre-defined schedule.
Support the Supplier Quality Management program by conducting supplier evaluations, audits, and supplier performance/metrics.
ISO 9001/17025: Participates in ISO 9001, ISO 17025, and other certification/accreditation activities.
Performs other duties as required.
Qualification & Experience
Master’s degree in science area (Chemistry, Biology) and a combination of skills and experience in the pharmaceutical or related industry.
A minimum of 8-12 years of experience in Quality, including developing and implementing a Quality Management System