QA Pharma Compliance Lead – Nutrition and Health

Job Listing No: 9740000

QA Pharma Compliance Lead – Nutrition and Health

This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP???s and the Quality Management System at the Madison site as needed to assure the compliance of products produced by DuPont with all internal, customer and regulatory requirements.
 
This position reports directly to the QA Manufacturing Lead ??? Pharma Project Lead and is directly responsible for the support, maintenance and verification of pharmaceuticals GMP???s compliance and Quality Management system at the Madison site.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES
 
The essential functions of this position include, but are not limited to, the following:
Develop procedures to ensure compliance of GMP and GLP
activities with applicable regulations and to maintain and grow Management
Systems including but not limited to: training, external and internal
audits, laboratory controls, deviations and CAPA (Corrective and
Preventative Actions).Participate in the review and approval of validation
documentation.Responsible for the review and assessment of deviations
and CAPA.Review and approve master batch records (both
production and QC) for compliance with various internal and external
requirements.Participate and represent Quality in MOC (Management of
Change) process.Ensure audit readiness for pharmaceutical compliance to
regulatory and client inspections; participate during audits.Conduct periodic internal audits to monitor
pharmaceutical cGMP compliance with established procedures and practices.Support completion of customer information and
documentation requests for pharmaceutical customers.Responsible for the coordination, trending and
reporting of Annual Product Review.Coordinate systems between Corporate Q&FS and the
site.Interact at various levels with other departments and
regulatory agencies; communicate to key stakeholder???s information
concerning pharmaceutical GMPs and Quality related topics.Ensure adherence to DuPont???s Quality and Environmental
Policies and Procedures.Comply with all company policies, including maintaining
a drug free work place.Support an environment of continuous improvement within
the assigned area and develop awareness for product and production
quality.Qualifications:Must have a Bachelor???s degree in Engineering, Microbiology, Biology, Food Science, or related field, and a minimum of 10 years of experience in Quality Assurance or Quality Control, cGMP???s, or Regulatory Compliance within the Pharmaceutical industry. Must be results driven with the ability to develop strong relationships internally and externally as well as have absolute integrity and strong influence and leadership skills.Experience working in a pharmaceutical GMP environment (ICH Q7).Must possess effective communication, interpersonal, team-building skills at various levels with other departments.Team-based problem-solving of manufacturing quality events.

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