- 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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