More Information
- Experience Level Senior
- Total Years Experience 5 and more years
- Education College 2 years
- Language Required English
- Disclosure Only selected candidates will be invited for interview
PharmEng Technology, one of the leading pharmaceutical consulting firms in the world with offices in USA, Canada and Asia, is hiring a full time, experienced Quality Assurance Technologist . This is a full-time position of 40 hours per week and available immediately.
Responsibilities:
• Develop Quality Assurance Programs
• Collect and compile operational or experimental data such as preparation of the URS/IQ/OQ/PQ protocols, execution & reports for the Facilities & Utilities;
• Oversight of change controls, NCs and deviations from initiation to close out, execution of all commissioning / qualification / validation protocols and CAPAs;
• Work cross-functionally with manufacturing/design engineers, quality engineers and production technicians to resolve the root cause of non-conformance and propose corrective and preventative action;
• Develop Commissioning & Qualification (C&Q) leveraging strategy and I/O/PQ execution on bioprocess equipment;
• Prepare Functional and Design Specifications, Development and Testing, Equipment and Systems, Risk Assessment, Source Code Review, 21 Part 11 ERES Assessment, Qualification Need Assessment, Design Qualification, Validation Plan, Traceability Matrix and Validation Summary Report
• Participate in Production Readiness Reviews, perform review of parts, drawings, bill of materials and work instructions for assembly/manufacturability;
• Identify requirements, schedule calibration, verify, and validate production tools and jigs for efficient manufacturing process
• Collect and compile operational or experimental data such as preparation of the URS/IQ/OQ/PQ protocols, execution & reports for the Facilities & Utilities;
• Oversight of change controls, NCs and deviations from initiation to close out, execution of all commissioning / qualification / validation protocols and CAPAs;
• Work cross-functionally with manufacturing/design engineers, quality engineers and production technicians to resolve the root cause of non-conformance and propose corrective and preventative action;
• Develop Commissioning & Qualification (C&Q) leveraging strategy and I/O/PQ execution on bioprocess equipment;
• Prepare Functional and Design Specifications, Development and Testing, Equipment and Systems, Risk Assessment, Source Code Review, 21 Part 11 ERES Assessment, Qualification Need Assessment, Design Qualification, Validation Plan, Traceability Matrix and Validation Summary Report
• Participate in Production Readiness Reviews, perform review of parts, drawings, bill of materials and work instructions for assembly/manufacturability;
• Identify requirements, schedule calibration, verify, and validate production tools and jigs for efficient manufacturing process
Qualifications:
• Completion of a two- or three-year college program or equivalent in industrial engineering technology;
• Familiar with Malaysia and ASEAN quality guidelines and requirements;
• Minimum 10 years of experience in similar role in the Pharmaceutical and
• Familiar with Malaysia and ASEAN quality guidelines and requirements;
• Minimum 10 years of experience in similar role in the Pharmaceutical and
Biopharmaceutical industries;
• Experienced Quality Assurance Validation, Commissioning, Qualification, and Validation (CQV), Change Management (Quality Management Systems), Project Management, Risk Assessment, GMP Training, GMP Compliance Audit and Process Engineering
• knowledge of cGMP, PIC/s, GAMP, ISO, EMA, FDA and JP regulatory requirements.;
• Experienced Quality Assurance Validation, Commissioning, Qualification, and Validation (CQV), Change Management (Quality Management Systems), Project Management, Risk Assessment, GMP Training, GMP Compliance Audit and Process Engineering
• knowledge of cGMP, PIC/s, GAMP, ISO, EMA, FDA and JP regulatory requirements.;
Salary
49.06 /hrLocation:
23 Lesmil Road, Toronto, ON, M3B 3P6
49.06 /hrLocation:
23 Lesmil Road, Toronto, ON, M3B 3P6
Position:
Permanent, Full-Time
Benefits:
You will also be enrolled in all Company benefit programs after the probationary period has been successfully completed.
• Life Insurance
• Accidental Death
• Long Term Disability
• Dental and Healthcare
• RRSP Group Savings Program (After 12 months of Service)
You will also be enrolled in all Company benefit programs after the probationary period has been successfully completed.
• Life Insurance
• Accidental Death
• Long Term Disability
• Dental and Healthcare
• RRSP Group Savings Program (After 12 months of Service)
How to apply
By email
tracy.g@pharmeng.com
By email
tracy.g@pharmeng.com
Exp. December 8, 2020