Energy Jobline ZR
Quality Assurance Manager for Pharmaceutical Packaging in Fairfield
Energy Jobline ZR, Fairfield, Connecticut, us, 06828
We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility.
The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada).
Overall Responsibilities For Quality Operations And Initiatives, Including
Quality Assurance management:
Documentation control (master batch record, specification and method)
Batch record review and product disposition
Investigations, complaints, deviations, CAPAs, APRs
Production and Pharmaceutical Development support
APRs, GMP training and SOP review
Validation / qualification documentation review and approval
QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
Develop, maintain, and enhance training programs and systems
Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives.
Must be able to move about the facility
Experience with FDA Audit
Extensive knowledge of US and EU current Good Manufacturing Practices
Experience with a CDMO would be preferable
In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for:
Quality Compliance management:
All audits, internal, external - regulatory, client and vendor
Vendor management program
QA Agreements with clients & contractors
License renewals
Company Description We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada).
Overall Responsibilities For Quality Operations And Initiatives, Including
Quality Assurance management:
Documentation control (master batch record, specification and method)
Batch record review and product disposition
Investigations, complaints, deviations, CAPAs, APRs
Production and Pharmaceutical Development support
APRs, GMP training and SOP review
Validation / qualification documentation review and approval
QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
Develop, maintain, and enhance training programs and systems
Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives.
Must be able to move about the facility
Experience with FDA Audit
Extensive knowledge of US and EU current Good Manufacturing Practices
Experience with a CDMO would be preferable
In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for:
Quality Compliance management:
All audits, internal, external - regulatory, client and vendor
Vendor management program
QA Agreements with clients & contractors
License renewals
Company Description We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr