Serialization SME at Combined Computer Resources

Combined Computer Resources

US, United States of America
October 20, 2020
FULL TIME
Engineering
Apply You will be redirected to Combined Computer Resources's preferred application process.

Serialization SME

LOOKING FOR A SERIALIZATION VALIDATION SENIOR ANALYST TO ACT AS A LIAISON BETWEEN ENTERPRISE SOLUTION AND GLOBAL QUALITY TO SUPPORT SERIALIZATION SOLUTION COMPLIANCE WITH GLOBAL QUALITY STANDARDS. WILL PROVIDE HANDS-ON SUPPORT AND GUIDANCE FOR COMPLIANCE WITH QUALITY POLICIES, CGXPS, 21CFR PART 11, EU ANNEX 11, AND OTHER APPLICABLE QUALITY REGULATIONS. WILL BE RESPONSIBLE FOR ADMINISTERING PGS BT SERIALIZATION VALIDATION PROJECT AND ENSURING PROPER IMPLEMENTATION. DEVELOP RISK ASSESSMENTS, SYSTEM IMPACT ASSESSMENTS, VALIDATION PLANS, PROTOCOLS AND REPORTS SUPPORTING VALIDATION OF SERIALIZATION SYSTEMS. INVESTIGATE DEVIATIONS, WRITE INVESTIGATION REPORTS AND CREATE SUMMARY REPORTS. PERFORM PERIODIC REVIEWS OF SERIALIZATION SOLUTIONS AND SOPS. PROMOTE COMPLIANCE POLICIES, CGMP AND OTHER REGULATORY COMPLIANCE IN ALL ASSIGNED PROJECTS. ACQUIRE AND MAINTAIN IN-DEPTH AND UP-TO-DATE KNOWLEDGE OF PRODUCT SERIALIZATION, SERIAL NUMBER MANAGEMENT PROCESSES, TRACK AND TRACE AND AUTHENTICATION REGULATIONS AND INDUSTRY STANDARDS. EXPERIENCE IN WRITING AND EXECUTING IQ, OQ, AND PQ FORMS AND PROTOCOLS FOR GMP UTILITIES, EQUIPMENT, SYSTEMS, AND SOFTWARE. INDUSTRY EXPERIENCE IN PHARMACEUTICAL, BIOTECH, MEDICAL DEVICE DESIGN, CONSTRUCTION, COMMISSIONING, VALIDATION, OR QA. GENERAL EXPOSURE AND EXPERIENCE IN A DISCIPLINE WITH KNOWLEDGE AND UNDERSTANDING OF PHARMACEUTICAL. DESIGNBUILDCOMMISSIONVALIDATE PROCESSES AND HOW THEY RELATE TO REGULATORY

REQUIREMENTS

AND CGMP REGULATIONS. EXPERIENCE IN MULTIPLE GMP VALIDATION DISCIPLINES (PROCESS EQUIPMENT, UTILITY, AUTOMATION, COMPUTER SYSTEMS, STERILIZATION) WITH ADVANCED TECHNICAL KNOWLEDGE.

Apply You will be redirected to Combined Computer Resources's preferred application process.
Job Expires: November 19, 2020

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