Validation Project Manager
6 days ago
Who are we?:
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries.
Our solutions focus on four different Business Lines:
Information System & Digital, Telecom, Life Sciences and Engineering.
We're focused on building and nurturing a top talent community where all our team members can achieve their full potential.
Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.Brief Call:
Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is - the number may vary depending on the level of seniority required for the position).
During the interviews, you will meet people from our team:
your line manager of course, but also other people related to your future role.
We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you.
Of course, you will also get to know Amaris:our culture, our roots, our teams, and your career opportunities
Case study:
Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you
Job description:
We are looking for dynamic Consultants to grow our
Life Sciences team in Montreal**. Your experience, knowledge, and commitment will help us to face our client's challenges.
You will be supporting different projects through your expertise as
Validation Project Manager to handle the coordination, implementation and monitoring of activities related to the installation and qualification of new equipment: autoclave, sealer, washer, hood.
Your main responsibilities:
- Perform and assist with qualification and validation of new and existing equipment, utilities, facility, and processes with the focus on GMP compliance
- Review and approve deviation/nonconformance/change control/CAPA (events) reports and records from validation/qualification perspective
- Review qualification and validation documentation of equipment, utilities, facility, and processes with the focus on GMP compliance
- Maintain the equipment validation program and review all validation documents in the validation lifecycle to ensure compliance
Qualifications:
- Bachelor's Degree in Chemistry, Biochemistry, Microbiology, Engineering
- At least 2 years of experience in pharmaceutical companies as a Validation Specialist
- Strong knowledge of GMP
- Knowledge of IQ, OQ, PQ
- Solid understanding of validation requirements
- Excellent communication skills in French and English
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