Quality Assurance- Pharmaceutical
McDonald Green - Cambridge, ON

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TITLE: Quality Assurance (positions available in different levels and areas)
LOCATION: Brantford
PROFILE: Pharmaceutical Company
DATE POSTED: JULY 17
DESCRIPTION/REQUIREMENTS:
- VALIDATION SPECIALIST MUST PROVIDE KEY CONTRIBUTIONS TOWARD DEVELOPNG STRATEGIES AND PLANS FOR ENSUREING REGULATORY COMPLIANCE AND CONTINUAL QUALITY IMPROVEMENT INITIATIVE RELTED TO VALIDATION LIFECYLCLE MANAGEMENT OF PRODUCTS AND PROCESSES.
- RESPONSIBLE FOR SCHEDULING, DESIGNING AND COORDINATING PROCESS AND CLEANING VALIDATION STUDY EXECUTION
- MONITORING PROCESS AND CLEANING METHOD DEVELOPMENT
- POSSESS EXEEPTIONAL PROJECT MANAGEMENT SKILLS
- QUALITY ASSURANCE AUDITOR WILL TEST DATA AND PRODUCTION DOCUMENTATION TO ENSURE TECHNICAL INTEGRITY OF THE WORK AND COMPLIANCE WITH CGMP , ENSURE SPECIFICATIONS ARE ADHERED TO AND CURRENT MASTER PRODUCTION AND CLEANING DOCUMENTS ARE APPROVED
- AUDIT DOCUMENTATION RELATED TO CONTRACTS
- OVERSEE DELEGATED DEPARTMENTAL DEVIATIONS OR OTHER SYSTEMS AND RESOLVE ISSUES AND CONDUCT FOLLOW UP ACTIONS
- PREPARE REPORTS , REVIEW AND APPROVE MASTER PRODUCTION RECORDS
- THE QUALITY ASSURANCE – COMPLIANCE SPECIALIST WILL OVERSEE SCHEDULING, COORDINATION AND EXECUTION OF INTERNAL AND EXTENAL AUDIT PROGRAMS
- PARTICIPATE IN REGULATORY AGENCY AND CUSTOMER SITE AUDITS AND ON-GOING MONITORING OF COMPLIANCE OF SYSTEMS AND PROGRAMS TO MEET REGULATORY REQUIREMENTS
- APPROVE CHANGES TO MASTER DOCUMENTS SUBMITTED THROUGH THE “CHANGE CONTROL SYSTEM”

QUALIFICATIONS:
- MUST HAVE UNIVERSITY DEGREE IN RELATED SCIENTIFIC DISCIPLINE
- MUST HAVE EXPERIENCE IN PHARMACEUTICAL INDUSTRY
- PRACTICAL EXPERIENCE IN APPLICATION OF GLOBAL CGMP


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