Mankind Job Vacancy For M Pharmacy With Industrial Experience
Required Position:
Group Leader/Assistant Group Leader
JOB DESCRIPTION:
•Supervise the lab experiments/ compatibility/ QbD studies activities, to provide the technical inputs to finalize the formulation and manufacturing process. To evaluate the Q1/02/03 assessment.,
•To do literature review regarding the developmental products, key information of the RLD, SBOA information search, review of patent landscape about the projects.
•To review the lab notebooks online, maintain the lab do the document lab scale activities in Lab, note book & maintain relevant documentation online.
•To compile and review lab scale batches stability data for insight for the development activity.
•To coordinate with cross functional team including analytical, packaging. regulatory, intellectual property departments and productions departments.
•To involve in the filter validation and external lab studies like D-value study, to send the samples, review the protocols and reports.
•API & Excipients vendor's finalization, Container and closures finalization.
•To involve SAP QMS, technology transfer related activities.
•To involve trial, scale-up and submission batch executions in production site.
•To prepare product specifications as per ICH/USP monographs/regulatory guidance documents. Preparation of justifications for specifications.
•To prepare product trial batch documents, risk assessment reports, sampling plan and technology transfer documents, stability protocols and product development report for submission.
•Compilation of the stability and development studies data, presentation and scientific discussion of the data with seniors and management, planning of new trials based on the outcome of compiled data.
•Response to the regulatory regarding the query raised for the formulation and process with sound scientific justification.
•To intimation of shortage raw materials, lab wares, spare parts of lab
equipment's etc.
•Excellent written and verbal communication and presentation skills
•Excellent people skills
If your profile matches with the above requirement, please mail your CV to careers.rnd@mankindpharma.com
Kindly mention the Department in the
subject line.
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| Mankind Job Vacancy For M Pharmacy With Industrial Experience |
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