Amneal Pharmaceuticals multiple openings for MDI/DPI – Inhalation R&D (OSD Dosage Form).
Hi,
We have multiple openings for MDI/DPI – Inhalation R&D (OSD Dosage Form).
Location: SEZ, Ahmedabad
Qualification: M.Sc / B. Pharma / M. Pharma
Experience: 5-18 Yrs
Position: Sr. Manager / Manager / Sr. Executive / Executive
Details: (For Manager / Sr. Manager)
1) Sound knowledge of sophisticated instruments like HPLC, GC, GCMS, LCMS, Karl Fischer Titrator, ACI, NGI, ADSA, FD-10, etc.
2) Experienced in facing different Regulatory Audits like USFDA, EU, etc.
3) To have awareness and understanding about the regulatory requirements/guidance of USFDA, EU, etc.
4) Hands-on experience of MDI-DPI dosage form for various tests like APSD by ACI & NGI, DDU, Drug content, Spray pattern, Related compounds, etc.
5) To handle a team of analysts / Work planning and distribution.
6) To guide & support all scientists for routine CMC activities like Exhibit batch release, Stability Sample analysis, Validation/Verification, Method Transfer of the drug product and drug substance for MDI & DPI dosage forms.
7) Analytical data review for all CMC activities.
8) Review of Method of analysis, specifications, SOPs, Change control, COAs, Stability protocols.
9) To handle OOS, OOAL & investigation reports.
10) Troubleshooting for day-to-day analysis.
For Executives / Sr. Executives:
1) Method Development, Stability, Method Validation & routine analytical activities for MDI DPI.
2) Operation and troubleshooting of MDI/ DPI instruments like NGI, ADSA, PSD, DUSA, etc. for day-to-day analysis.
3) Hands-on experience of HPLC, GC, GCMS, LCMS, Karl Fischer Titrator, etc.
4) Preparation and review of Standard test procedure, approval of specifications, analytical methods, SOPs, and change control.
Literature search and DMF review.
5) Coordinate with inter & Intra department contact for related issues.
Knowledge of Stability evaluation, Tech Transfer, and query work.
Please share your profile at [email protected], if interested
Regards,
Puja Sinha
HR
Amneal Pharmaceuticals Pvt. Ltd.
