QA EXECUTIVE

Icm Pharma Pte. Ltd.

Early Applicant

17 days ago
Be among the first 50 applicants

Exp: 2-5 Years

3,000 - 4,000 SGD/m

Full time

Singapore

Job Description

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)