|
Reference Number:
4960IL_QA_TK
Job Description:
Description:
? Supports quality compliance systems and objectives within the division.
? Maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements.
? This position will interact with cross-functional groups such as Quality Control, Regulatory Affairs and Production. Responsible for product release.
? Ensure approved quality systems are established and maintained. Proactively and continuously improves Alpharma?s internal processes and products with quality mindset.
? Report on FDA and regulatory compliance inspections.
? Assist with developing remediation efforts and FDA response when necessary.
? Perform internal compliance, surveillance and focused audits.
? Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report. Perform vendor and supplier quality audits to assure quality of incoming materials and services as necessary.
? Maintains and/or monitors compliance tracking systems and archive records, e.g. document control, deviation reporting, calibration, records retention, records destruct, etc.
? Understands and follows GMP/GLP/GCP regulations Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations.
? Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, MSDS, etc.
? Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects. Performs technical reviews and approves validation documents, design review, engineering reviews, IQ/OQ/PQ, quality support reports, protocols, final reports and miscellaneous project documentation.
? Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation.
Qualified candidates will have a Bachelor?s Degree in a scientific field .
? A minimum of 5 years scientific field preferably in a FDA regulated industry.
? The position requires approximately 20% domestic travel and occasional international travel.
? Experience in Canadian, EMEA or Latin American regulated regions desired.
? CQA certification desired.
Must possess strong oral and written communication skills and the ability to work independently.
Experience Level:
4 Years
Requirements:
|
