Walk-in || Quality Control Analyst At Immacule Life Sciences-4 – 9 years
Time and Venue
- 22nd September – 25 September , 10.00 AM – 5.00 PM
- Immacule Lifescience Pvt. Ltd. (Corporate Office) 1109 – 1115, Solitaire Connect, Near BMW Showroom, Makarba, Ahmedabad – 380015 (View on map)
Role & responsibilities
- Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples.
- Conduct testing of injectable products as per approved specifications, STPs, and pharmacopoeial requirements.
- Handle instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, pH Meter, Karl Fischer, Dissolution Apparatus, and analytical balances as applicable.
- Perform assay, related substances/impurities, identification, pH, water content, particulate matter, clarity, and other applicable tests for injectable products.
- Ensure proper sampling, testing, documentation, and timely release of analytical results.
- Prepare and maintain analytical worksheets, raw data, test reports, logbooks, and other QC records.
- Follow GLP, GMP, data integrity (ALCOA+) and laboratory safety requirements.
- Investigate and report Out of Specification (OOS), Out of Trend (OOT), and laboratory incidents/deviations as per procedures.
- Support method validation, method verification, method transfer, analytical method development, and instrument qualification activities.
- Perform calibration, verification, and routine maintenance of QC laboratory instruments as per SOPs.
- Maintain proper laboratory housekeeping and ensure availability of chemicals, reagents, standards, and consumables.
- Support stability study testing and maintain stability-related documentation.
- Coordinate with QA, Production, Microbiology, and other cross-functional departments for timely completion of testing and investigations.
- Participate in internal audits, regulatory inspections, and customer audits as required.
- Ensure compliance with current IP, BP, USP, Ph. Eur. and other applicable pharmacopoeial requirements.
- Follow all applicable company SOPs, safety procedures, and EHS requirements.
Preferred candidate profile
Hands-on experience in pharmaceutical QC laboratory operations, preferably injectable manufacturing.
Practical knowledge of HPLC and other analytical instruments.
Knowledge of GMP, GLP, OOS/OOT, deviation, CAPA, change control, and data integrity.
Good understanding of pharmacopoeial testing and analytical procedures.
Good documentation and communication skills.
Ability to work independently as well as in a team.
Willingness to work in shift operations, if required.