Quality Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Key Responsibilities :

The Quality Operation Specialist is responsible for the execution of quality oversight relevant activities that maintain GMP compliance in shopfloor, engineering and warehouse through appropriate vigilant and mentorship from QA Manager, ensuring site compliance with GMP requirement and corporate policies and procedures is maintained.

This position will have a significant impact on the QA team, ensuring the site's quality compliance and finding opportunities for continuous improvement. Ensure timely delivery of our dedication to Regulatory and Clients.

• Responsible for QA oversight and Coordinate shop floor routine compliance.
• Responsible for reviewing and approving all GMP documents from functional teams.
• Collect shop floor firsthand information and work with operations team to do problem solving.
• Review and approve Master Batch record and master formulation records.
• Review usage logbooks, GMP data on routine and non-routine basis in shop floor.
• Ensure all time readiness of site for GMP and or client audits.
• Participate in deviation and OOS investigation as quality representative.
• Involve in Process validation and clean validation quality review and approval.
• Establish QA Operations procedures and continually seek ways to improve the procedures.
• Any other appropriate job-related activities assigned by the supervisor.
• Participate in hosting client and regulatory audit.

EHS

• Understand and ensure implementation of EHS procedures and safe systems of work.
• Ensure Compliance with EHS rules, signage, and instructions at all times.
• Ensure promptly reporting of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications

Education:

• Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area.

Experience:

• 1 - 3 years of Quality Assurance experience in pharmaceuticals preferred. Fresh graduate with relevant qualifications may also be considered.
• Experience in QMS, QA operation, Experience in biologics and aseptic training is an asset.
• Experience in site data integrity management.

Proficiencies:

• Knowledge in cGMP and Regulatory Compliance and GMP Quality Management System.
• Effective Systematical Thinking and Communication ability.
• Good teamwork and partnership.
• Results oriented.
• Good at problem solving and Quality Risk Management knowledge.