Immediate Need - Quality Control - Stability (Formulation)

8 - 10 years

8 - 12 Lacs

Posted:2 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

Job Responsibilities:

1. Handling of stability section independently.

2. Handling of additional stability studies, such as, Photo stability, In-use studies, freeze thaw studies. Split studies etc.

3. Preparation of stability protocols, reports and stability compilation.

4. Responsible for timely initiation, closure of QMS documents related Quality Control and implementation respective corrective and preventive action. (i.e. Change controls, Laboratory Incidents, OOS, OOT & CAPA)

5. Responsible to follow ALCOA + principle while doing the data recording.

6. Review of In-process, finished, stability, process validation, in-process, Raw material, Excipients, packing material, hold time study samples, analytical validations, verification's, transfers, calibrations, Qualifications, quality control laboratory instruments usage logs and GLP activities, etc.

7. Involvement of Laboratory instruments qualifications, calibrations and schedules.

8. Conducting trainings of laboratory employees.

9. Preparation & review of Laboratory documents such as, SOPs, Specifications, STP’s, GTP’s, Protocols, Reports and COA’s Documents as per cGMP.

10. To maintain good laboratory practices in the laboratory as per the respective SOP’s instructions, all time FDA readiness and ensuring of Lab and data compliance.

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