Experience

Belco Pharma

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Chemist

  • Sep 2020 - Present

  • Responsible for analysis of In-process and finish product samples as per approved specification and standard testing procedures. • Responsible for analysis of stability sample of finish products as per approved protocol. To maintain all logbooks in relevant sections as per approved procedures.• Responsible for calibration/validation of instruments in laboratory. • To prepare analysis reports of all products on daily basis. To maintain product related working and reference standards records.• To maintain chemical, reagents and glassware records required for in process and finish product working. To execute method validation as per approved protocol. • To prepare the testing procedures and specification related to product testing and review the same as on required.• Assist in preparation of dossier in CTD and ACTD format and preparation of documents of process validations.• Involved in preparation of documents for stability study and test reports of various products, raw materials and packaging materials in a defined process.• Assist is preparation of the dossiers as per prescribed guideline of respective RA.• Research of various pharmacological, preclinical and toxicological data based on circulated literature.• Compilation of NDA and ANDA document to submitted to respective RA.