QA Manager GMP
Company: CPS, Inc.
Location: Euclid
Posted on: February 20, 2021
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Job Description:
QA Manager GMPQuality Assurance (QA) Manager with in-depth
experience in small molecule drug substance development,
manufacturing and characterization in compliance with GMP and GLP
guidelines. Reporting to the General Manager, the QA Manager will
provide Quality oversight and support to the Technical Operations
group for the manufacture and characterization of non-clinical,
clinical and commercial products in compliance with GMP and GLP
guidelines. The QA Manager will be accountable for establishing and
driving Quality initiatives, maintaining/improving quality
infrastructure and participating where needed on various CMC
related project teams. The QA Manager will be accountable for
assuring compliance with company's Quality System,
identifying/driving quality system improvement, quality oversight
at the project level and generation of metrics to drive continuous
improvement.Responsible for the review and approval of quality
documentation including quality agreements, project protocols,
validation plans, batch records and associated analytical data
related to the manufacture and characterization of drug substances
and drug products* Responsible for the disposition of drug
substances and drug products* Review and approval of deviations and
resulting investigation reports, corrective actions and/or
preventative actions for adequacy and logic of root cause analysis,
and impact to both quality and regulatory commitments* Perform
in-study and in-process audits to assure compliance of operational
activities* Responsible for supplier and material qualification
supporting GMP manufacturing* Establish and administer program to
assure data integrity* Administer Quality Management System
databases for change control, deviations, and CAPAs* Responsible
for corporate archives and document control* Establish and
administer corporate training program* Manage inspections by
Regulatory Authorities* If you'd like to hear more about this
opportunity and others we are currently working on, please contact
Tory Mack at tmack@cps4jobs.com.JO: 311.20TMRequirements* BS or
equivalent in a technical discipline and a minimum of 7-10 years of
experience of in the pharmaceutical / biotech industry* Must have
at least 5 years of experience in Quality Assurance supporting
manufacturing and characterization of small molecule drug substance
for clinical and commercial use in a contract environment* Working
knowledge and technical understanding of the manufacture and
testing of small molecule drug substance and drug product*
Knowledge of GMP and GLP principles with respect to FDA and EMA
regulations and guidelines* Knowledge of drug development process*
Experience in deviation investigations, root cause analysis, risk
assessment and developing corrective action plans* Experience in
data integrity / 21CFR Part 11 Compliance* Experience in process
validation, analytical method validation and equipment
qualification* Excellent communication and documentation skills*
Experience managing multiple priorities and quality assurance
staff* Ability to prioritize and re-prioritize on a daily basis* If
you'd like to hear more about this opportunity and others we are
currently working on, please contact Tory Mack at
tmack@cps4jobs.com.JO: 311.20TM
Keywords: CPS, Inc., Euclid , QA Manager GMP, Executive , Euclid, Ohio
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