Thermo Fisher Announces Quality Assurance Job Opening | Pharma Graduates Apply
Looking for a Quality Assurance Job with a global life sciences leader? Thermo Fisher Careers has announced an exciting opportunity for the position of Quality Specialist II in Bangalore, Karnataka. This full-time onsite role is ideal for candidates with a Bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmacy, or a related field and experience in quality or regulatory functions. Explore the complete eligibility criteria, responsibilities, qualifications, and application details for this Quality Assurance Job through Thermo Fisher Careers below.
- Job Title: Quality Specialist II
- Location: Bangalore, Karnātaka, India
- Job ID: R-01355651
About the Company
Thermo Fisher Scientific is a global leader in serving science, delivering innovative technologies, laboratory solutions, and healthcare products that help customers make the world healthier, cleaner, and safer. Through Thermo Fisher Careers, professionals have the opportunity to work on meaningful projects that improve lives worldwide while building successful long-term careers.
Job Description
- The CoE Post-Market Surveillance (PMS) Specialist supports global Business Unit (BU) PMS teams by maintaining and updating approved PMS documentation as part of ongoing lifecycle surveillance activities.
- This role operates within a centralized Center of Excellence model, leveraging standardized processes, templates, and best practices to ensure efficiency, consistency, and compliance.
- The Specialist updates previously approved PMS reports (e.g., PMSR, PSUR, PMPF, Literature Reviews) using analyzed data provided by BU PMS teams. The CoE does not perform final approval; BU PMS teams retain full legal responsibility for product oversight and report approval.
- This role ensures PMS reports are reviewed and updated at least annually and remain inspection-ready and compliant with applicable regulations (e.g., IVDR EU 2017/746).
Key Responsibilities
- Update approved PMS reports (PMSR, PSUR, PMPF, Literature Reviews) using BU-provided data
- Ensure timely annual or periodic updates of PMS documentation
- Maintain version control and document traceability
- Compile and integrate BU data into standardized templates
- Ensure clarity, accuracy, and audit readiness of documentation
- Identify inconsistencies or potential safety signals and escalate to BU teams
- Collaborate with BU PMS teams to gather inputs and incorporate feedback
- Deliver draft reports to BU teams for review and approval
- Apply standardized templates and support process improvements
Qualifications
- Education: Bachelor’s degree in Pharmacy or related field
- Experience: 1–3 years in medical devices, IVD, or regulatory/quality environment
Skills Required
- Strong technical writing skills
- Data interpretation and analytical ability
- Close attention to detail
- Familiarity with IVDR/MDR preferred
- Proficiency in Microsoft Office
Scope of Role
In Scope:
- Updating and maintaining PMS reports
- PMS document lifecycle management
- Supporting centralized PMS processes
Out of Scope:
- Approval of PMS reports (BU responsibility)
- Quality event tracking/investigation
- Regulatory submissions (e.g., EUDAMED)
Key Success Factors
- Timely delivery of compliant PMS reports
- Strong collaboration with BU teams
- Consistent use of templates and processes
- Maintenance of audit-ready documentation
