QA for QC Manager
Morris Plains (Morris) Design / Civil engineering / Industrial engineering
Job description
Job Description
Establish/ implement quality systems and programs new Analytical transfers, process validation, and Analytical CMC section authoring/reviewing. Provide QA oversite for QC ( review/approved test records, SOP’s, C of A’s Deviations, CAPA’s, protocol and reports related to QC labs Set up standards in providing the QC team with QA guidance and decisions Reviews/Approve documentation associated with a given product Establish systems and programs for disposition of QC data within LIMS as QA oversite Establish method validation protocol and reports approach for MP Establish QA operational landscape for SAP QM and performs SAP transactions, as required Drive activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure Establish independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending for QC. Develops meaningful quality KPI’s with the QC team and participate in Quality Management Review meeting to discuss trends Implementation and ensures adherence of appropriate regulations and quality standards. Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans, and specifications, as needed. Review and approve trend reports (environmental, product, OOS, OOE, reference/control, etc) Establish a training program for QC analysts for lab specific quality systems and compliance Drive continues quality improvement program for QC laboratory and partner with the QC team to implement/optimizes to improve efficiency (right the first time- Analytical and documentation) and monitor/escalate as needed. Establish/ define the QC self-inspections / DI programs with compliance team Prepare and participate to health authorities inspections and internal audits to present QA in QC quality systems Support regulatory filings. Provide cGMP and associated OJT training to other members of QA in QC and other QC areas as needed. Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
Posting Title
QA for QC Manager
Desired profile
Minimum requirements
PhD or MSc or BS in Pharmacy, Biotechnology, or Chemistry English fluent in speaking and writing. PhD: 6+ years QA related experience with 2+ years in QC lab related, or, MS or equiv: 7+ years’ QA related experience with 2-3+ years in lab related , or, BS: 8+ years QA related experience with 3+ years in lab related
Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience. Related experience in supporting an operational quality control lab. Must have a working knowledge of regulatory (FDA, EMEA Etc.,,) requirements as well as industry quality management tools, standard, and quality systems. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
Job Type
Full Time
Country
USA
Work Location
Morris Plains
Functional Area
Quality
Division
Novartis Technical Operations
Business Unit
NTO BTDM
Employment Type
Regular
Company/Legal Entity
Novartis Pharmaceuticals
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.