We are Urgently Hiring for – MDI/DPI – QC at Amneal Pharmaceuticals, Ahmedabad Location.
Department: Quality Control
Designation : Sr. Manager / Manager
Job Location: Ahmedabad
Job Description :
· Hands on experience of QC for MDI-DPI dosage form.
· Well experienced of facing different Regulatory Audits like USFDA, EU etc.
· To handle a team of 15 to 20 analyst.
· Knowledge & experience of GLP, GDP.
· To have well awareness and understanding about the regulatory requirement/guidance of USFDA, EU etc.
· Having experience for performance of various test like APSD by ACI & NGI, DDU, Drug content, Spray pattern, Related compounds, Plum geometry etc.
· Having knowledge of all sophisticated instruments like HPLC, GC, GCMS, LCMS, Karl Fischer Titrator, ACI, NGI, ADSA, Spray pattern etc.
· Experienced of handling OOS, OOAL investigation reports.
· To have knowledge of Extractable and Leachable studies of MDI-DPI dosage form.
· To guide & support all scientists for routine CMC activities like Exhibit batch release, Stability Sample analysis, Validation/Verification, Method Transfer of drug product and drug substance.
· Analytical data review for all CMC activities.
· Review/finalization of Method of analysis, specifications, SOPs, change control, COAs, Stability protocols.
· To handle Troubleshooting for day-to-day analysis.
· Knowledge of In vitro BE study and Product characterization studies of MDI-DPI dosage form for US & EU regulatory guidance will be an added advantage.
· Minimum 15 Years of total experience and at least 5 years of group leading.
· Should be a motivation leader.
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