Computer Systems Validation Specialist
2 weeks ago
Proud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.
Key Responsibilities- Develop and coordinate IT Computerized GxP System Validation and Infrastructure Qualification deliverables
- Perform Impact and Risk Assessments for Computerized Systems (GAMP 5)
- Develop, review, coordinate, and participate in the development of validation documentation: Validation Plan, URS, Specifications, IQ/OQ/PQ/Data Migration/Cut-over Protocols, Trace Matrix, Validation Summary Reports, etc...
- Provide guidance and recommend validation strategy, approaches, and testing to IT and Project Teams
- Participate in System Periodic Reviews and System Retirement
- Ensure new and existing implemented IT Computerized GxP Systems are validated and compliant with all applicable regulations (Health Canada, US FDA CFR Part 11, EU Annex 11, etc...)
- Ensure infrastructure components are qualified
- Ensure IT Change Controls are assessed for impact, resolution is documented, tested, and approved to maintain the systems validated state
- Provide training of IT Computer System Validation procedures and FDA CFR 21 Part 11 to Project Teams
- Participate in IT Supplier Evaluation and Qualification of vendors
- Participate in internal and external audits ensuring IT is compliant to regulatory expectations, PMS internal policies, and procedures
- Develop IT SOPs and training material
- Recommend improvements to validation and qualification processes
- Maintain knowledge of current GMP, Quality, and Compliance policies and industry good practices for Quality Systems into IT Department
- Knowledgeable of Health Canada, GAMP 5, CFR 21 Part 11, and current Good Manufacturing Practices
- Able to execute validation strategy on the activities surrounding the implementation of IT Computerized Systems
- Able to analyze requirements, assess risk, and determine the degree of compliance evidence necessary to satisfy compliance requirements
- Good planning, prioritization, analysis aptitudes, and able to manage simultaneous project rollouts
- Good communication skills
- Good judgment in degree of compliance and risk
- Good organization, problem-solving, and decision-making skills
-
Computer Systems Validation Specialist
3 weeks ago
Montreal, Quebec, Canada Pharmascience Full timeJob Title: Computer Systems Validation SpecialistProud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.Job Summary:The Computer...
-
Computer Systems Validation Specialist
3 weeks ago
Montreal, Quebec, Canada Pharmascience Full timeJob Title: Computer Systems Validation SpecialistProud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.Job Summary:The Computer...
-
Computer Systems Validation Specialist
2 months ago
Montreal, Quebec, Canada Pharmascience Full timeAbout Pharmascience Pharmascience is a Canadian company with a global presence and a history in the pharmaceutical industry since 1983. We specialize in generic drugs and value the human touch, offering a stimulating work environment based on trust, cooperation, and dedication to going the extra mile. About the Role The Computer Systems Validation...
-
Computer Systems Validation Specialist
4 weeks ago
Montreal, Quebec, Canada Pharmascience Full timeAbout Pharmascience Pharmascience is a Canadian company with a global presence and a history in the pharmaceutical industry since 1983. We specialize in generic drugs and value the human touch, offering a stimulating work environment based on trust, cooperation, and dedication to going the extra mile. About the Role The Computer Systems Validation...
-
Computer Systems Validation Expert
2 months ago
Montreal, Quebec, Canada Pharmascience Full timePharmascience is a leader in generic drugs, with a global reach and a strong commitment to the human touch. Our stimulating work environment is built on trust, cooperation, and a willingness to go the extra mile. We're seeking a skilled Computer Systems Validation Specialist to guide the validation of our Computer systems. The ideal candidate will have a...
-
Computer Systems Validation Expert
2 months ago
Montreal, Quebec, Canada Pharmascience Full timePharmascience is a leader in generic drugs, with a global reach and a strong commitment to the human touch. Our stimulating work environment is built on trust, cooperation, and a willingness to go the extra mile. We're seeking a skilled Computer Systems Validation Specialist to guide the validation of our Computer systems. The ideal candidate will have a...
-
Computer Systems Validation Specialist
1 month ago
Montreal, Quebec, Canada Pharmascience Full timeComputer Systems Validation SpecialistProud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.Key ResponsibilitiesDevelop and...
-
Computer Systems Validation Specialist
1 month ago
Montreal, Quebec, Canada Pharmascience Full timeComputer Systems Validation SpecialistProud to have been at the forefront of our industry since 1983, Pharmascience is a leader in generic drugs. We are a Canadian company with a global reach for whom the human touch is important. Our work environment is stimulating, based on trust, cooperation, and going the extra mile.Key ResponsibilitiesDevelop and...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a key role in the validation of complex equipment and systems at the Royalmount and Dorval site. As a team member, they will collaborate with other validation team members on their projects. The Specialist acts as a validation project manager, ensuring that all stages of the project are followed in...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a crucial role in the validation of complex equipment/systems at the Royalmount and Dorval site. As a team member, they will collaborate with other validation team members on their projects. The Specialist acts as a validation project manager, ensuring that all stages of the project are followed in...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a key role in the validation of complex equipment and systems at the Royalmount and Dorval site. As a team member, they will assist other validation team members in their projects. The Specialist acts as a validation project manager, ensuring that all stages of the project are followed in accordance with...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a key role in the validation of complex equipment and systems at the Royalmount and Dorval site. As a team member, they will assist other validation team members in their projects, ensuring that all stages of the project are followed in accordance with standard procedures (health and safety, Good...
-
Software Validation Specialist
4 weeks ago
Montreal, Quebec, Canada Cs Workx Full timeSoftware Validation SpecialistCs Workx is a leader in the development and certification of safety-critical systems in the aerospace, electric and autonomous driving industries. We are seeking a highly skilled Software Validation Specialist to join our team.Key Responsibilities:Test embedded software applications on aircraft and space systems such as engine...
-
Software Validation Specialist
4 weeks ago
Montreal, Quebec, Canada Cs Workx Full timeSoftware Validation SpecialistCs Workx is a leader in the development and certification of safety-critical systems in the aerospace, electric and autonomous driving industries. We are seeking a highly skilled Software Validation Specialist to join our team.Key Responsibilities:Test embedded software applications on aircraft and space systems such as engine...
-
IT Validation Expert
2 months ago
Montreal, Quebec, Canada Pharmascience Full timeAbout PharmasciencePharmascience is a leading generic drug company with a global presence. We pride ourselves on our commitment to quality and compliance, and we're looking for a skilled professional to join our team.Job SummaryWe're seeking a highly experienced Computer Systems Validation Specialist to guide the validation of our computer systems. This is a...
-
IT Validation Expert
2 months ago
Montreal, Quebec, Canada Pharmascience Full timeAbout PharmasciencePharmascience is a leading generic drug company with a global presence. We pride ourselves on our commitment to quality and compliance, and we're looking for a skilled professional to join our team.Job SummaryWe're seeking a highly experienced Computer Systems Validation Specialist to guide the validation of our computer systems. This is a...
-
Systems Engineer
3 weeks ago
Montreal, Quebec, Canada Rs Computer Full timeAt Rs Computer, we're committed to innovation and sustainability. Our team of experts develops and markets cutting-edge mobility solutions that pave the way for a greener future. As a Systems Engineer, you'll be part of a passionate and multidisciplinary team that's shaping the future of transportation.Your ResponsibilitiesDesign and optimize systems to...
-
Systems Engineer
3 weeks ago
Montreal, Quebec, Canada Rs Computer Full timeAt Rs Computer, we're committed to innovation and sustainability. Our team of experts develops and markets cutting-edge mobility solutions that pave the way for a greener future. As a Systems Engineer, you'll be part of a passionate and multidisciplinary team that's shaping the future of transportation.Your ResponsibilitiesDesign and optimize systems to...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a crucial role in ensuring the quality and safety of our equipment and systems at the Royalmount and Dorval site. As a key member of our validation team, they will collaborate with other team members to deliver high-quality projects.Key ResponsibilitiesDevelop and execute validation protocols for...
-
Montreal, Quebec, Canada Pharmascience Full timeThe Equipment and Systems Validation Specialist plays a crucial role in ensuring the quality and safety of our equipment and systems at the Royalmount and Dorval site. As a key member of our validation team, they will collaborate with other team members to deliver high-quality projects.Key ResponsibilitiesDevelop and execute validation protocols for...
