Key Responsibilities
Perform analysis of raw materials, in-process, finished products, and stability samples.
Conduct testing using analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, and Dissolution Apparatus.
Prepare reagents, standard solutions, and test samples.
Maintain accurate laboratory records and documentation as per GMP and GLP.
Review analytical data and report results.
Perform instrument calibration / Validation and routine maintenance.
Investigate out-of-specification (OOS) and out-of-trend (OOT) results with guidance from senior staff.
Ensure compliance with SOPs, GMP, GLP, and safety requirements.
Support method verification, validation, and laboratory audits.
Required Skills
· HPLC operation and troubleshooting
· GC analysis
· UV-Visible Spectrophotometer
· FTIR analysis
· Dissolution testing
· Wet chemistry analysis
· Analytical method execution
· GMP and GLP compliance
· Good Documentation Practices (GDP)
· OOS/OOT investigation (basic knowledge)
· Instrument calibration
· MS Office (Excel, Word)
Preferred Experience
· Oral solid dosage (OSD) pharmaceutical products
· Stability studies
· Raw material and finished product analysis
· Regulatory compliance (USFDA, WHO-GMP, MHRA, NEFDAC, EU-GMP preferred)
· Laboratory documentation and data integrity (ALCOA+ principles)
Qualifications
· B.Sc./M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related field.
· 2–5 years of experience in a Quality Control laboratory within a pharmaceutical manufacturing company.
Preferred Candidate
· Experience in a GMP-regulated pharmaceutical environment.
· Good analytical and problem-solving skills.
· Strong attention to detail and documentation practices.
· Ability to work independently and as part of a team.
· Willingness to work in shifts, if required.