Job Description
Job Description
Duties:
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Manage and supervise a quality assurance (QA) team, including hiring, training, education and coaching.
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Direct and manage the Quality Management System and all other aspects of the Quality Assurance Department on a day-to-day basis for the assurance of drug quality, strength, identity, and purity throughout the manufacture, processing, packing, testing, and holding of the drug product.
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Develop and manage programs to improve quality and ensure that quality goals align with business objectives and regulations.
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Responsible for the establishment of inspection standards to be used by the Quality Assurance Department.
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Responsible for administering the auditing program to assure that all operations are periodically audited for compliance to cGMP requirements.
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Direct and manage the Change Control Committee ensuring that the Document Control Procedures are applied to all proposed changes, including, but not limited to the review and approval of any changes to the facility, equipment, product and manufacturing changes to ensure compliance with applicable regulations.
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Daily operations of the Quality Assurance Department.
Qualification
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B.S. in Science Curriculum (Chemistry, Biology, Pharmacy) or a related science.
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A minimum of 5+ years' managerial experience in a related field, preferably in the pharmaceutical industry in a quality assurance environment.
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Experience in all aspects of Quality Assurance functions with in-depth knowledge of cGMP's.
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Strong communication skills (written and verbal)
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Ability to problem solve
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Retain information as strictly confidential.