Job description
About the job
Develop, review and/or approve validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely fashion.
Lead project validation activities and provide basic guidance and direction to junior project engineers as required.
Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
Manage qualification execution and lead validation deviation investigation encountered in qualification.
Collaborate with multi-functions to arrange, plan and ensure smooth running of the qualification activities.
Able to manage cross-function stakeholders, and to lead /facilitate meeting and discussion relevant to project qualification/ validation activities.
Participate in site Validation Maintenance Program.
Support Change Implementation on site.
Any other tasks as and when assigned by Supervisor or Project Lead.
About you
Bachelor\xe2\x80\x99s Degree in Engineering/ Science or other related scientific fields
At least 5 years of experience in Equipment Qualification in the pharmaceutical/biotech industry.
Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred.
Good knowledge and experience of the practical and theoretical requirements of validation programs in GMP facility
Good oral and written communication skills
Meticulous and Systematic
Team player, with a strong focus on safety, quality and timeline
Equal opportunity
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
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 \xe2\x80\x93 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\xe2\x80\x99re 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.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here\'s what our recruitment process looks like:
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 3 - 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.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate\'s shoes to ensure they have the best possible experience.
We look forward to meeting you!
MNCJobz.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.