17 Oct
|
BKM Health
|
Ahmedabad
17 Oct
BKM Health
Ahmedabad
Job highlights
Maintain proper documentation of test results,certificates of analysis (CoA),batch records,and specifications
Ensure compliance with Valuable Laboratory Practices (GLP) and industry standards
. Hands-on experience with analytical instruments (HPLC,GC,UV,FTIR,Dissolution)
Conduct HPLC, GC, UV Spectroscopy, FTIR, Dissolution, and other analytical tests as per standard operating procedures (SOPs).
Develop and validate analytical methods for raw materials, intermediates, drug substances, and finished products.
Ensure methods are suitable for quality control, stability studies, and regulatory submissions.
Analysis of formulation, API, and stability. (In-process / Intermediate / BU / CU / Assay / Dissolution / RS)
Ensure compliance with Valuable Laboratory Practices (GLP) and industry standards.
Conduct stability studies as per ICH guidelines and prepare related reports.
Maintain proper documentation of test results, certificates of analysis (CoA), batch records, and specifications.
Ensure compliance with GMP, WHO, USFDA, MHRA, EU-GMP, and other regulatory guidelines.
Participate in internal and external audits and assist in audit preparations.
Conduct periodic calibration and validation of laboratory instruments.
Hands-on experience with analytical instruments (HPLC, GC, UV, FTIR, Dissolution).
Knowledge of pharmacopoeial guidelines (USP, BP, EP).
📌 Adl Executive Ahmedabad
🏢 BKM Health
📍 Ahmedabad