Greetings From Gland Pharma Ltd!!!
We are hiring for Manufacturing ScienceAnd Technology Department.
Qualification: M.Sc. / B. Pharma / M. Pharma
Experience: 3-8 Years
Job Location: Hyderabad
Job Roles:
•Responsible for the activities of various lifecycle management changes of developed products for regulated markets in timely manner.
•Understand the scope of the project and feasibility check and gap analysis to develop appropriate process requirements.
•Preparation of budget and its approval based on the scope of the project.
•Preparation and review of technology transfer documents and assessing the gaps against the current systems and involve in the transferring the technology of commercialized products to other manufacturing sites.
•Procurements of API / RM/PM/Consumables and its follow-up with purchase and QC for receipt, sampling, testing and approvals.
•Review of specifications, STP for project related materials.
•Preparation of Submission batch BPCR’s, Submission batch protocols, process validation protocols, stability protocols and other study protocols like photo stability, temperature cycling and temperature excursion.
•Preparation of reports pertaining to all the above protocols.
•Conducting the pre-Submission batches meeting with internal team to ensure there is effective technology transfer (no deviations and quality issues).
•Follow-up with internal departments and with client to close deviations, change controls and incidents of the project.
•Responsible in involve/monitor of trial, submission and process validation batches that are manufactured for stability initiation within the stipulated timeline.
•Ensure that, all the required documents for dossier compilation are provided to Gland regulatory in timely manner. Support to Gland DRA, to provide the documents to client for dossier filing and update the stability data to client, etc…
Interested candidates can share profile to [email protected]