Job Description
REQUIREMENTS:
Bachelor's degree in Science or related field from an accredited college or university, and 7+ years pharmaceutical quality assurance experience, or an equivalent combination of education and experience.
Current Good Manufactuirning Practices (cGMP),and Food and Drug Administration (FDA) and other regulatory requirements and compliance standards.
Advanced principles of effective auditing.
Principles and practices of mathematical and statistical computations, technical and scientific writing, and budget administration and financial reporting.
Business, scientific and personal computer hardware and software applications.
Business English usage, spelling, grammar and punctuation.
Pharmaceutical principles, practices and their applications.
Leadership and training methods and techniques.
Directing, coordinating, delagating assignemnts and reviewing the work of assigned department personnel.
Responding to inquiries from management, employees and regulatory agencies.
Communicating clearly and concisely, both orally and in writing.
RESPONSIBILITIES:
Under limited supervision, manages, plans and directs the quality auditing and quality systems for the Quality Assurance Department to assure compliance with current Good Manufacturing Practices and regulatory and corporate policies.
Carries out management responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Manages quality systems related to issuance and control of item number's, packaging component specifications and approved material lists.
Assures deviations/investigations are closed prior to final batch release/raw materials release.
Monitors updates of all appropriate databases, and maintains the proper QA controls necessary for entering status in the BPCS System.
Other Duties as may be assigned.
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