Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading global speciality pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology, Women's Health and Nephrology (Medical). Watson has commercial operations in many of the world's most established and growing international markets.
Post: Quality Auditor
Job Description:
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Review and release raw, intermediate and finished materials and products, as well as their corresponding batch records.
• Interface with manufacturing, warehouse, and QC materials management to ensure timely and accurate shipment of materials and products.
• Audit data from Quality Control, vendors’ certificates aof analysis, and other relative warehouse documentation of products and materials.
• Prepare, revise and verify SOP, QSMS, IQ/OQ, Swab Data and clinical releases.
• Monitor environment as needed.
• Maintain Quality Assurance documentation files, databases, and logs.
• Tack Quality Assurance calibration.
• Assist in preparing budgets and reviews.
• Prepare and conduct GMP training or Manufacturing and Quality Assurance staff as needed.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.
Candidate Profile:
Knowledge of:
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Principles of auditing and performance evaluations.
• AQL sampling and inspection principles and techniques.
• Principles of mathematical and statistical computation and analysis.
• Business, scientific and personal computer hardware and software applications.
• Business English usage, spelling, grammar and punctuation.
• Pharmaceutical principles, practices and their applications.
• Current Company policies, practices and procedures, including safety rules and regulations.
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Skill in:
• Observing, analyzing and troubleshooting problems, identifying alternative solutions, projecting consequences of proposed actions and implementing methods, procedures and/or techniques for resolution to support Company goals.
• Reading, interpreting records, reports, business, personal and scientific computer data, certificates of analysis and conformance and other applicable data sources
• Responding to inquiries from management, employees and regulatory agencies.
• Communicating clearly and concisely, both orally and in writing.
• Operating scientific, business and personal computers.
• Interpreting and applying Federal, state and local policies, procedures and regulations.
• Establishing and maintaining cooperative working relationships with others.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and frequent business travel. Work is performed in an office environment.
Qualification:
Two (2) years pharmaceutical quality assurance auditing experience.
Education:
Bachelor’s Degree in Science or related field from an accredited college or university.
An equivalent combination of education and experience may be substituted.
Additional Information:
Experience: 2 Years
Location: Salt Lake City, UT-USA
Education: BS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Job ID: 7925BR
End Date: 30th Sept., 2011
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