QC Analyst
NewBe an early applicantKey Responsibilities
- Perform routine and non-routine analysis of pharmaceutical finished products, and stability samples using HPLC, GC, Dissolution, and other analytical techniques
- Ensure all testing is carried out in compliance with GMP, SOPs, and regulatory requirements
- Accurately document all analytical data, observations, and deviations in accordance with ALCOA+ principles
- Perform equipment calibration, qualification, and routine maintenance as required
- Troubleshoot analytical methods and instruments, and escalate issues when necessary
- Assist in method development and method transfer activities where applicable
- Support laboratory investigations, OOS, and deviation reports with technical input
- Provide support and guidance to junior analysts and contribute to their technical development
- Maintain lab cleanliness, safety, and regulatory compliance at all times
Occasional Duties
- Perform routine analysis of finished products for physical parameters, including: Average Weight, Uniformity of Weight, Disintegration, Friability, Hardness, Water content by Karl Fischer (KF),Identification tests (chemical, UV, IR),Loss on Drying (LOD), and product Description
Candidate Requirements
Minimum Qualifications & Experience:
- A relevant science degree (e.g., Chemistry, Pharmaceutical Sciences, Biochemistry, etc.)
- Minimum of 6 years of experience in a GMP-regulated pharmaceutical testing laboratory
- Strong hands-on experience with HPLC, GC, and Dissolution is essential
Essential Skills:
- Sound understanding of analytical chemistry principles and GMP compliance
- Familiarity with analytical instruments and software (e.g., Empower, Chromeleon)
- Good organizational, communication, and problem-solving skills
- Ability to work independently and collaboratively in a fast-paced environment.