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