ROLE SUMMARY
To perform and review chemical analysis of raw materials, in-process materials, intermediates, finished products and stability samples using approved methods and laboratory instruments.
KEY RESPONSIBILITIES
To perform and review chemical analysis of raw materials, in-process materials, intermediates, finished products and stability samples using approved methods and laboratory instruments.
Well-versed with analytical software.
To maintain usage log book for HPLC, Mobile phase &to maintain all the records usage log book as per requirement. To verify working standard/Impurity Standard& reference standard usage log records. To ensure vial destruction record. analysis for working standard & check report of the same.
To do planning, and check reporting for column performance. To Handling and record holding time study and validation activities. To review temperature record of HPLC room / balance room. To maintain maintenance record of lab instrument for HPLC section instrument.
Handling activity of excel sheet preparation and validation. Handling activity of incident and deviation. Handling activity of OOT, OOS and planning the hypothesis testing as per test report. Working on HPLC having privileges of Reviewer.
To prepare COA. To review of data on HPLC, GC, GC-HS, IR, UV etc. To prepared new method on HPLC, GC, GC-HS as per MOA.
To perform QMS related activities. To prepare SOPs.
To handling activity of calculator validation. To planning preventive maintenance/maintenance of instrument. To handling qualification and validation of instrument.
QUALIFICATIONS & EXPERIENCE
B.Sc. or M.Sc. in Chemistry, Industrial Chemistry, Pharmaceutical Chemistry, or a related discipline.
5-8 years of Quality Control experience in chemical analysis within the pharmaceutical API or regulated chemical manufacturing industry.
TECHNICAL COMPETENCIES
Chemical analysis, HPLC/GC/GC-HS/UV, cGLP, data integrity and laboratory documentation
WHAT WE OFFER
Competitive salary and performance-based bonuses.
A supportive and dynamic work environment with clear career growth opportunities.
Comprehensive medical insurance, pension, and other employee benefits.