Vacancy at Dr. Reddy’s, as a Lead Development QA
1.Ensure the quality system followed in the product development space
2.Ensure quality compliance of develomental products in Cell line development, Process development, Functional analytics, Product analytics and Non-commercial GMP Manufacturing and Testing activities.
3.Review and approval of Product Development documents. Ensure data authentication, archival and retrieval of documents.
4.Review for quality compliance of executed process and analytical records of development campaign.
5.Ensure quality compliance of establishment and qualification of Cell banks related to PD projects to meet the requirements of cGMP
6.Timely evaluation and closure of incidents/Change controls. Ensure the CAPAs are effectively implemented
7.Ensure phase-gate compliance of technology transfer of products from development to operations.
8.Ensure analytical method validations in ASAT as per regulatory expectations
9.Ensure Product Life cycle management (LCM) by updating and tracking activities and documents to support regulatory interface.
10.Release of development materials for pre-clinical studies and issuance of CoA.
Knowledge of Biologics product development
Bachupally, Hyderabad, Telangana, India
Years Of Exp
8 to 12 Years
Lead Development QA
Drafted by Nagama Nadaf
A technophile who is crazy about technology and passionate about blogging.
I care by sharing recent advancements in technology and trying to reach out to the minds of people