The posting
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



