Senior QC Scientist

Main Responsibilities:

• Manage QC test samples, including in-process, release, environmental monitoring, drug substance, and excipient samples.

• Oversee stability sample management to ensure proper storage, tracking, and testing schedules.

• Maintain regulatory retention samples and reference samples in compliance with applicable requirements.

• Ensure accurate documentation and traceability of all sample management activities.

• Support laboratory operations by coordinating sample receipt, storage, distribution, and disposal.

• Ensure all QC activities are conducted in compliance with cGMP, data integrity, and EHS requirements.

About You:

• Bachelor's Degree or higher in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.

• 3–5 years of experience in the biotechnology, biopharmaceutical, or pharmaceutical industry.

• Strong understanding of the drug development lifecycle and quality control processes.

• Solid knowledge of cGMP requirements and a strong quality and compliance mindset.

• Familiarity with global regulatory requirements and guidelines, including FDA, EMA, NMPA, ICH, WHO, USP, Eur. Ph., and ChP.

• Good understanding of regulatory submissions, including IND/IMPD, NDA, and ANDA filings.

• Strong organizational, documentation, and communication skills.

• Ability to work effectively in a fast-paced and regulated environment.

Contract Duration: 12 months