AVEVA DRUG DELIVERY SYSTEMS INC

Discussion

Team Leader

Open 31d

Should be responsible for batch release

Monitor stability schedule and ensure analysis is performed timely

Review of Specification and STP

Preparation and review of SOP

Raw Data review review for Finished product batch release

Preparation of various protocols such as stability study, hold time study, photostability study, Freeze thaw study

Participate in OOS/ OOT and deviations investigations and ensure timely closure of the same.

Support RA department by providing all the required documents for product filing

Ensure VQ is done for all RM,PM,API suppliers and maintain record for the same.

Ensure compliance of the AMV laboratory, software qualification of various instruments in AMV lab

Should visit CMO/CTL for data review

Ensure qualification of equipment done

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AVEVA DRUG DELIVERY SYSTEMS INC
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Research Associate

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AVEVA DRUG DELIVERY SYSTEMS INC
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Senior Research Associate

Open 30d Senior

Assist in the execution of process technology transfers and Commercial batches at manufacturing sites (in-house and CMO). Conduct scale-up, exhibit batches and commercial batches under supervision, ensuring proper docum…
AVEVA DRUG DELIVERY SYSTEMS INC
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Team Leader, RA

Open 30d

Lead and manage end-to-end regulatory activities predominantly for US ANDA submissions and post-approval lifecycle management for complex sterile dosage forms. Guide and supervise a team of 4–5 senior regulatory associa…
AVEVA DRUG DELIVERY SYSTEMS INC
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Open 30d

Assist in the execution of formulation and process technology transfers from R&D to manufacturing sites (in-house and CMO). Conduct scale-up and exhibit batches under supervision, ensuring proper documentation and p…
AVEVA DRUG DELIVERY SYSTEMS INC
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Associate Director, Commercial Tech Lead

Open 30d Lead

Lead Commercial batch manufacturing and technology Transfer activities to internal and external (CMO) manufacturing sites for solid orals, liquids, softgel, parenteral and semisolid dosage forms. Drive CMO selection bas…

regulatory-compliance
AVEVA DRUG DELIVERY SYSTEMS INC
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QA Associate I - PR

Open 30d North America

Review, approve, and release manufacturing, packaging, and clinical batch records along with auxiliary documentation. Prepare product release summaries and create Certificates of Analysis/Certificates of Compliance as a…