Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position purpose/responsibilities:
As a PDS QA Project Specialist at Thermo Fisher Scientific Inc., you will play an integral role in our mission to deliver outstanding products and services. This opportunity allows you to be at the forefront of innovation in the Information Technology sector, ensuring that our products meet the highest standards of quality. Your contributions will be vital in achieving flawless execution and compliance with industry regulations, while collaborating with an ambitious and diverse team.
Specific tasks/primary activities:
- Batch Release Control:
Assist the QP and Quality Operations Manager in releasing product batches, ensuring compliance with specifications by verifying documents and analyzing batch records.
Ensure accurate archiving of all documentation related to batch records in compliance with standards and company procedures.
- Investigation Record Review:
Conduct preliminary assessments of deviations and complaints, assign initial criticality levels, and determine the need for further discussion with management.
Review the investigation plan, support the investigator in identifying root causes and corrective and preventive actions.
- Client Management and Inspections:
Participate in periodic meetings with clients and provide outstanding support via email by responding to quality queries.
Draft performance metrics for clients and actively participate in client site visits.
Lead audit preparation and support the presentation of relevant topics during audits.
- Compliance:
Ensure the successful execution of assigned training for the profile.
Ensure the continuous updating of SOPs by drafting documentation in compliance with current GMP requirements.
Review MBRs of products related to clinical and commercial batches.
Review change controls.
Review protocols and reports related to clinical batches.
Draft PSFs in agreement with current SOPs and ensure their continuous updating.
Issue Risk Assessments for the area of competence.
Review FMEAs.
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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