Quality Assurance Expert

2 days ago


Singapore Thermo Fisher Scientific Full time

Company Overview

Thermo Fisher Scientific is a world leader in serving science, empowering our colleagues to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions.

We are committed to providing the resources and opportunities our colleagues need to make a difference in our world while building a fulfilling career with us.

Job Description

The Quality Operation Specialist plays a crucial role in ensuring site compliance with Good Manufacturing Practices (GMP) requirements and corporate policies and procedures. This position will have a significant impact on the QA team, ensuring the site's quality compliance and finding opportunities for continuous improvement.

The key responsibilities of this role include:

  • Ensuring timely delivery of quality oversight relevant activities that maintain GMP compliance in shopfloor, engineering, and warehouse environments.
  • Reviewing and approving all GMP documents from functional teams.
  • Collaborating with operations teams to resolve problems and improve processes.
  • Coordinating shop floor routine compliance and ensuring all time readiness of sites for GMP and client audits.
  • Participating in deviation and OOS investigation as a quality representative.
  • Involved in process validation and clean validation quality review and approval.
  • Establishing QA Operations procedures and continually seeking ways to improve them.

EHS Responsibilities

This role also involves understanding and implementing Environmental, Health, and Safety (EHS) procedures and safe systems of work. The successful candidate will ensure compliance with EHS rules, signage, and instructions at all times and promptly report any accidents, near misses, or breaches of rules.

Required Skills and Qualifications

To be successful in this role, you will require:

  • A Bachelor's Degree in Life Sciences or Chemical/Biochemical Engineering, or a related scientific field.
  • At least 3 years of experience in Quality Assurance, preferably in pharmaceuticals.
  • Knowledge of cGMP and Regulatory Compliance, as well as Quality Management Systems.
  • Effective systematical thinking and communication skills.
  • Good teamwork and partnership abilities.
  • Results-oriented approach with strong problem-solving and Quality Risk Management knowledge.

Benefits

We offer a competitive salary and benefits package, as well as opportunities for growth and development within our organization.



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