PURPOSE
Interprets federal and state and/or international regulations as they apply to laboratory and manufacturing processes supporting GMP operations. Identifies and/or leads key projects for continual improvement of compliance at the site and may extend to other site operations as appropriate.
RESPONSIBILITIES
Manage investigations, deviations, escalations and internal & external complaints
Leads management of technical customer complaints by investigating and resolving compliance problems, questions. Assists and provides guidance in complaints received from other units of the company, customers, government regulatory agencies, etc.
Evaluates the received communications on product complaints and inquiries, performs follow-up with the complainant and enters the information into the Complaints database.
Performs complaint investigations, coordinates additional investigational activities as needed within Operations and Site Services and/or third party contractors/manufacturers.
Assesses returned complaint samples, performs retention sample evaluations, reviews batch documentation and writes the complaint investigation reports.
Trends and analyzes complaints as per applicable procedures (i.e. investigation reports, quarterly trend reports).
Compiles data and reports monthly metrics for product complaints in the Site Quality Council meetings.
Is a Qualified Trainer for the Product Complaint Group and performs training for new employees at the direction of QA Management.
Provides complaint data for Annual Product Review (APR) Reporting.
Provides complaint data for Deviation Investigations (if applicable).
Prepares the site for Health Authority Inspections including DEA audits. Participate in the follow-up of Health Authority Inspections, internal audits and self-inspection.
Adheres to all applicable procedures, cGMP s, company policies, and may develop and implement programs designed to increase employee awareness and knowledge of compliance policies at the site (laboratory and manufacturing).
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 for the site.
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.)
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.
Education: BS/BA required, advanced degree preferred
Languages: Fluent in written and spoken English
Experience: 8-10 years of professional QA experience in regulated, GMP pharmaceutical plant. Qualified candidates must have oral, solid dosage experience. Prefer QA oversight for technical customer complaints, FAR, and Compliance experience.
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