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Quality Assurance Manager-OTC Liquids Facility - Jupiter, United States - Vetio Animal Health
Description
Primary Function:
Responsible for the oversight of all Quality Assurance Operations in Vetio Animal Healths Animal OTC facility in Jupiter, FL, including those related to Quality Assurance and the Quality Management System as well as the quality of all products produced. The Quality Assurance Manager will ensure compliance with all local, state, federal, company, and customer requirements and maintain current regulatory registrations, permits, and cGMP regulations as they pertain to 21 CFR part 210 and 211.
Key Responsibilities:
Oversee and ensure compliance with all local, state, and federal regulatory requirements
Oversee and ensure compliance with all company and applicable customer programs and requirements designed for production safe, quality products
Ensure purity, quality, and composition of finished products
Maintain the final authority to approve or reject all procedures, specifications, controls, test methods, and results that impact the purity, quality, and composition of ingredients or products
Supervise and designate quality employee review and approval of all master manufacturing records, and all modifications to the master manufacturing records
Assure use of the most current revision of all documentation
Ensure the following Quality Programs are maintained according to cGMP standards:
o Corrective Action Preventative Action (CAPA)
o Deviation
o Quality Incident Reporting
o Complaint
o Change Control
o Training
o Internal Auditing
o Quarantine/On Hold
o Supplier Qualification and Foreign Supplier Verification
Review and approve equipment, process, and cleaning validations
Review and Approve laboratory control processes and testing results, as needed
Review and approve the documentation for qualification of suppliers, both foreign and domestic
Create, review, and sign customer quality agreements and other quality related documents
Have the authority for disposition of raw material, in-process materials, finished products, and packaging materials
Oversight of raw material, packaging, and finished product specifications
Have the authority of control and release of withheld and retained product
Responsible for hosting customer and regulatory auditors
Responsible for responding to customer and regulatory audit observations
Performs other related duties as assigned by management.
Skills & Knowledge Required:
Extensive Knowledge FDA CFR 210 and 211 requirements
At least 10 years experience managing a Quality Control and/or Quality Assurance group
At least 10 years experience in FDA/GMP environment
GMP Professions certification preferred
Experience communicating with customers
Experience hosting and/or participating in regulatory audits
Ability to manage multiple projects and prioritize demands
Strong organizational skills
Strong analytical skills with attention to detail
Supervisory Responsibilities:
