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Jobs in Singapore   »   Jobs in Singapore   »   Quality Assurance / Control Job   »   QA EXECUTIVE
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QA EXECUTIVE

Icm Pharma Pte. Ltd.

Icm Pharma Pte. Ltd. company logo
  • REVIEW, ISSUE & APPROVAL OF BATCH MANUFACTURING RECORDS
  • CONDUCTS GMP TRAINING TO PRODUCTION OPERATORS
  • ASSIST AUDITORS DURING EXTERNAL AUDITS
  • REVIEW OF SOP/MASTER BATCH RECORDS/SPECIFICATIONS/LABORATORY METHODS & GMP RELATED DOCUMENTS AS PER REGULATORY FILINGS
  • COMMUNICATION WITH PRODUCTION ON UPDATES
  • MANAGEMENT OF CHANGE CONTROLS AS QUALITY CO-ORDINATOR, RESPONSIBLE FOR REVIEW OF CHANGES, QUALITY ASSESSMENT, TRACKING FOR COMPLETION AND CLOSURE OF CHANGE CONTROLS
  • HANDLES PROCESS AND SYSTEM DEVIATION (DEVIATION INVESTIGATION, REPORT WRITING AND CAPA IMPLEMENTATION TRACKING)
  • DOCUMENT CONTROL SUCH AS SOP, MANUAL, FORMS, VALIDATION DOCUMENTS, ETC (CREATION, MONITORING, CONTROL, REVIEW, RETRIEVAL AND DISPOSAL
  • PREPARATION OF ANNUAL PRODUCT REVIEW
  • CONDUCT SELF-INSPECTION OF FACILITIES, OPERATIONS AND PROCEDURES TO ASSURE CONFORMANCE WITH GMP AND RELATED REGULATORY REQUIREMENTS
  • QUALIFICATION, APPROVAL AND AUDIT OF SUPPLIERS OF RAW & PACKING MATERIALS, CONTRACT MANUFACTURERS AND CONTRACT TESTING LABORATORIES TO ASSURE THAT THEY CAN SUPPLY PRODUCT THAT MEET ESTABLISHED REQUIREMENTS
  • ENSURE SAFE WORKING BY PRACTISING AND COMMUNICATING SAFETY
  • CHECKING AND SIGNING OF PRODUCT LABELS
  • VALIDATION AND QUALIFICATION: MUST HAVE EXPERIENCE OF HANDLING DESIGN/INSTALLATION/PERFORMANCE QUALIFICATIONS FOR FACILITY AND EQUIPMENT
  • VERIFICATION OF IMPORTED GOODS - CHECKING OF PACKAGING AGAINST APPROVED ARTWORK AND DOWNLOADING OF TEMPERATURE RECORDS
  • QUALITY RISK ASSESSMENT AND ANALYSIS
  • HANDLES CUSTOMERS'COMPLAINTS
  • TRENDING: DATA COLLECTION AND STATISTICAL ANALYSIS
  • FULFILLS THE ROLES OF THE MICROBIOLOGIST IN THE ABSENCE OF THE ASSIGNED AND ASSISTS IN MICROBIOLOGICAL VALIDATION
  • PARTICIPATING IN STABILITY STUDIES (MONITORING AND STORAGE OF SAMPLES)

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