Perform analytical testing of raw materials and finished pharmaceutical products using techniques such as HPLC GC UV-Vis FTIR and dissolution testing.
Develop optimize and validate analytical methods in accordance with ICH and pharmacopeial guidelines (USP BP EP).
Conduct method transfer activities between laboratories and ensure reproducibility of analytical procedures.
Execute stability studies and analyze samples in compliance with stability protocols.
Review and interpret analytical data ensuring accuracy integrity and compliance with ALCOA principles.
Prepare and maintain comprehensive documentation including SOPs protocols validation reports and certificates of analysis.
Investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective and preventive actions (CAPA).
Calibrate qualify and maintain laboratory instruments and ensure proper functioning.
Support internal and external audits and inspections by regulatory authorities.
Monitor laboratory inventory reagents and reference standards to ensure uninterrupted operations.
Perform analytical testing of raw materials and finished pharmaceutical products using techniques such as HPLC GC UV-Vis FTIR and dissolution testing.Develop optimize and validate analytical methods in accordance with ICH and pharmacopeial guidelines (USP BP EP).Conduct method transfer activities be...
Perform analytical testing of raw materials and finished pharmaceutical products using techniques such as HPLC GC UV-Vis FTIR and dissolution testing.
Develop optimize and validate analytical methods in accordance with ICH and pharmacopeial guidelines (USP BP EP).
Conduct method transfer activities between laboratories and ensure reproducibility of analytical procedures.
Execute stability studies and analyze samples in compliance with stability protocols.
Review and interpret analytical data ensuring accuracy integrity and compliance with ALCOA principles.
Prepare and maintain comprehensive documentation including SOPs protocols validation reports and certificates of analysis.
Investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective and preventive actions (CAPA).
Calibrate qualify and maintain laboratory instruments and ensure proper functioning.
Support internal and external audits and inspections by regulatory authorities.
Monitor laboratory inventory reagents and reference standards to ensure uninterrupted operations.
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