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


About this company
McDonald Green is proud to be the largest, locally owned, independent HR Consulting firm in the Tri City area. Founded in 1994 by Helen...