Location: Fremont, CA Description of Duties: Oversees development and implementation of validation strategies, policies, protocols, and other documentation for cGMP systems including: Electronic Document Management Systems, Manufacturing Equipment, Manufacturing Cleanrooms, Utilities, Quality Control Equipment Supervise staff and validation contractors in the planning and execution of validation activities.
Review and approve validation documents.
Develop and execute validation protocols to demonstrate systems are meeting design and functional requirements.
Perform analysis and compilation of data and results into summary and final reports.
Develop, organize, and execute the Validation Maintenance (Requalification) program.
Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
Perform reviews of executed manufacturing batch records for completeness, compliance, and accuracy Review and perform root cause analysis.
Perform vendor qualification activities.
Assist in managing and administrating the internal and external Quality systems including CAPA, deviation, change control, Lab Investigation, Product complaint, and Training.
Represent QMS records and actions during FDA and other regulatory inspections.
Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval.
Integration, preparation and distribution and review of product documentation, master batch records, etc.
to support operations and quality control departments consistent with corporate objective, GMP, and regulatory requirements.
Knowledge of the document management system.
Duties include but are not limited in supporting to generate, manage workflows, review and approval of documents.
Ensure document alignment with templates.
Works with document authors to correct issues.
Managing the quality review function and ensuring all quality documents, review and approve Master Batch Records, Engineering Drawings, Design History Files, Validation protocols reports and validation deviations, are reviewed in a timely manner.
Create KPI’s and present as part of Management Review Managing and administrating the GMP training program.
Supporting corporate driven initiatives to enhance the training system.
Manage and assist in activities during regulatory inspections.
Performs and assist internal and external audits.
Perform line clearance and QA oversight within the manufacturing facility during production when needed.
Position Requirements: BS degree in Chemistry, Engineering, Biology, Biochemistry or other relevant discipline.
Minimum 8 years of QA systems experience within Pharmaceutical or Medical Device At least 1 year of supervisory or management experience.
Broad validation experience in the pharmaceutical industry supporting cGMP facilities, equipment, EDMS, and utilities.
A thorough understanding of cGMP and QSR regulations.
CQA or CQE preferred