QC Senior Chemist

Job Description :

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Position Summary

Join Thermo Fisher Scientific's Quality Control team as a Senior QC Chemist. You will ensure cGMP and regulatory compliance while delivering analytical solutions through expertise in biologics chemistry, method qualification/validation, and timely project completion. Responsibilities include overseeing lab activities, leading investigations, and promoting quality culture and compliance across the site.

Responsibilities

• Support new equipment qualification, lab systems, and chemistry lab setup.

• Perform transfer/verification/validation of analytical methods.

• Prepare technical documentation (protocols, SOPs, reports).

• Conduct analysis of raw materials, intermediates, finished products, and stability samples under cGMP.

• Oversee sampling, testing, and release processes for process aids and packaging materials.

• Ensure timely chemistry testing (HPLC, GC, particle counting, etc.) to support production.

• Manage daily lab operations in compliance with GMP and company standards.

• Update processes in response to new pharmacopoeia/regulatory changes.

• Lead lab investigations/deviations and ensure timely closure per Quality System.

• Review analytical data for accuracy and compliance.

• Perform equipment maintenance and calibration.

• Troubleshoot analytical methods and equipment issues.

• Manage QC chemical, reference standard, and consumable inventory.

• Train and maintain training records for team members.

• Stay updated on international regulations (GMP, GLP, ICH, pharmacopoeias).

• Act as SME during audits/inspections.

• Support internal audits, inspections, and continuous improvement.

• Promote Quality Culture and 4i values.

• Adhere to HSE, GMP, and 5S standards.

• Support shift work as needed.

Minimum Requirements/Qualifications

Education:

• Bachelor's degree in Chemistry, Biochemistry, or Life Sciences.

Experience:

• Minimum 5 years in pharmaceutical/biotech Quality Control.

• Knowledge of FDA, EMA, HSA, PIC/S, and ICH regulations.

• Strong cGMP knowledge and QC chemistry techniques (HPLC, UPLC, CE).

• Experience with method transfer and validation.

• Excellent communication skills in English.

• Ability to work cross-functionally and under regulatory scrutiny.

• Audit and inspection readiness experience.