Interprets federal and state and/or international regulations as they apply to laboratory processes supporting GMP operations. Identifies and/or leads key projects for continual improvement of compliance in laboratories and may extend to other site operations as appropriate.
Assists with investigations and resolving compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
May develop and implement programs designed to increase employee awareness and knowledge of compliance policies in QC laboratories.
Prepare trend reports related to in-process monitoring, deviation reports, investigation reports and CAPAs.
Follow-up with functional department for timely completion of corrective and preventive actions recommended.
May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations.
This position provides Quality Assurance and cGMP Compliance oversight of Quality Control and Quality Laboratories.
This position will be responsible for identifying and managing key projects to drive continual improvement in laboratory compliance or other site processes, as appropriate.
Performs other duties as assigned.
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)
Key words: investigation, investigations, deviation, deviations, capa, capas, corrective, quality, quality system, GMP, cGMP, DEA, controlled substances, Trackwise, complaint handling, fda, far, field alert report, compliance
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements Position will be filled at level commensurate with experience.
BS/BA required, advanced degree preferred
Fluent in written and spoken English
6-8 years of professional experience preferred