Manager / Senior Manager Technology Transfer
Endo International
**Job Description Summary**
This role is in technology transfer of injectable products to manufacturing plant, scale up and demonstrate the technical capability to current portfolio and pipeline products. He would be responsible for Harmonization of Documentation, Evaluation, QMS activities and Monitoring of batches at Manufacturing site. The incumbent will also be jointly responsible for achieving targeted product execution/ Launch goals of department / organization.
**Job Description**
+ Harmonization of documents at site, related to technology transfer.
+ To perform evaluation and harmonization activities related to QMS and GMP documentation at site (As applicable)
+ To compile and interpretation of trials/Scale up/Submission/Validation batches outcome and results, drawing conclusions.
+ To prepare the response(s) of the regulatory queries. (As applicable)
+ To perform product transfer activities of injectable and complex injectable assigned by HOD/Designee.
+ To Plan and supervise the Scale up trials/Scale up batches/Submission batches.
+ Observance of the laid down standard operating procedure (SOP) as applicable at the all PAR formulation sites, including work place safety.
+ To carry out the Literature search on technical requirements, quality management, Regulatory Guidance (as applicable).
+ To prepare the product execution strategy along with HOD/ designee.
+ To Co-ordinate with cross functional teams for the timely completion of assigned activities.
+ To work out a project plan specifying timelines and target completion dates.
+ To support and participate in the Investigations, Deviations, Incidents, Out of Specifications, Out of Trends and Non-conformances as applicable to Technology Transfer.
+ To perform work allotted by HOD/ designee.
+ Bachelor of Pharmacy / Masters of Pharmacy (Full Time)
+ Required Experience: 12 – 16 yrs. of production operation-injectable/Technology transfer-injectable / In-depth Documentation experience for regulated market in injectable / Sterile products.
+ Good communication
+ Stake holder management
+ Work in transparent environment
+ Proactive
+ Innovative
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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