QA Consultant
3 days ago
Job description
About the job
Maintains a productive working relationship and interaction with various departments, such as Regulatory, Technical, Supply Chain, and the TPM sites.
Ensures that the manufacture of bulk drug substances and/or drug products takes place at TPM locations in accordance with local procedures, QA Operations' manufacturing specifications, and current GMP.
Review and approve manufacturing directions to the production floor.
Assist PQA with planning, risk analysis, and execution of international projects and events to ensure desired outcomes are attained.
Perform annual Product Quality Review.
Participates in Trend Review Board to monitor process track and trending.
Participates as a TPM representative in the Global Change Review Board (GCRB) meeting to assess global changes that affect all sites
Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved, including planning, risk analysis, and implementation
About you
Bachelor’s degree preferably in Engineering or Science
Knowledge of GMP regulations and standards affecting pharmaceutical products
Expertise in Quality Assurance, Compliance and or Manufacturing, Specific to APIs and Biologics
Strong analytical skills and attention to detail
Change plan, Exception Reports, SAP experience is highly preferred
Ability to effectively communicate across all levels of the organization
Highly developed problem solving and analytical skills
Equal opportunity
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 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.
We look forward to meeting you
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