Quality System Manager

Company: LanceSoft, Inc.
Location: Irvine
Posted on: February 19, 2021

Job Description:

Job Title: Quality System ManagerLocation: Irvine, CA 92618Duration: 06 Months+Description:--Responsible for management of personnel in Quality Systems including QA Documentation Control, QA Change Control, Quality Systems and QA GMP Training. --Leads and directs all activities relating to change control, documentation control, GMP training, annual product reviews, annual reporting, implementation and maintenance of Quality Assurance Systems to assure cGMP compliance. --Accountable for independent decisions affecting product quality in terms of quality systems, costs, and people.
Essential Duties & Responsibilities--Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow.--This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc.--Processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. Also, archival of records.--Collection, compilation, analysis, and review of all data and information supporting the validation status of a products including at least manufacturing, packaging, testing, sourcing, deviations, stability, and changes (Annual Product Review)--Management of formal process for issuing the batch manufacturing and/or packaging record with assigned batch numbers to operations for execution--Review/approval of all documentation associated with the validation of the procedure(s) used to clean the equipment train for a product's manufacturing and packaging process and cleaning verifications, Process validations and Validation master plans.--Review and approval of all continual improvement projects affecting Quality at a site.--Review/approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.--Tracking, trending, and reporting of Quality Metrics for site, regional, and global review.--Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.--Review of regulatory and quality compliance requirements and Corporate Standards, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.--Development and monitoring of corrective action plans where needed.--Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.--Requires degree in a scientific discipline or equivalent industry experience as listed below.--Prefers a BS degree in a scientific discipline or advanced education in Science or Life Science field.--10 - 15 years' experience in pharmaceutical manufacturing and/or testing.--No less than 10 years' experience in pharmaceutical Quality Assurance--Electronic Document Management Systems (EDMS), Management of more than 5 direct reports, Root Cause Analysis, Quality System Implementation, Continous improvement.-- Competencies: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it-- Demonstrates a thorough knowledge of Quality Systems, Documentation practices and general processes throughout Teva, including a good working knowledge of TPM system applications-- Thorough knowledge of cGMPs, FDA, EMEA and other regulatory guidelines-- Ability to evaluate new technology for implementation e.g. new TrackWise or LIMS workflows.-- Project Management skills for implementation of Goals and Objectives of the department-- Highly motivated, well organized, and able to develop alternative solutions to issues, including identifying, designing and implementing process improvements based on sound decision making skills.-- Supports changes initiated by partners, contract sites, contract laboratories or suppliers that directly impact product and/or procedures

Keywords: LanceSoft, Inc., Irvine , Quality System Manager, Executive , Irvine, California