Encube Ethicals is an integrated pharmaceutical company dedicated to topical formulations with 23+ years of experience in contract development and manufacturing. Our manufacturing facility in Madkaim – Goa, India is the largest single-site topical manufacturing facility in the world, dedicated to prescription and OTC pharmaceuticals, and cosmetic semisolid dosage forms. Encube’s R&D Centre in Mumbai, India houses a team of 150+ scientists working for the formulation development of topical products.
We are Hiring!!!!!
Senior Officer – Technology Transfer
Department : Technology Transfer
Experience : 2 – 7 Years
Location : Ponda (Goa)
* Initiation & review of Change Control, annexures for introduction of New Technology Transfer Products.
* Initiation & review of Temporary Change Control and deviation for Technology Transfer Products.
* Planning of batch manufacturing and packing dates along with plant planner and R&D.
* Ensuring the material inward & GRN for the new product at Goa. Coordination with SCM, R&D, QA and Plant Personnel for material inventory to use in execution of batches.
* Co-ordination with Production, Quality Control and Quality Assurance for completion & availability of necessary documents for product transfer.
* Review of master and executed documents (Batch Manufacturing Records, Batch Packing Records and Process Validation Protocols etc.) for Technology Transfer projects.
* Performing Gap analysis and Risk Assessments for Technology Transfer projects
* Generating request for SAP codes for materials pertaining to new products, artwork changes and source change.
* Processing of SAP operations for creation of Bill of material and Master Recipe for new product, new code QM formalities, Code modification and other related activities
* Co-ordination with QC department for Analytical method development/ transfer and validation of new products.
* Successful execution and monitoring of process optimization batch, Pre-exhibit, Exhibit, Process Assessment and Process Validation batches of new products.
* End to end Project management of Technology Transfer projects with R&D, customers and Plant.
* Co-ordination with Packaging Development, Purchase, Stores, Quality Control and Quality Assurance for material inventory for Technology Transfer Projects.
* Co-ordination with Production and Engineering for checking availability of necessary machine change parts for Technology Transfer Projects.
* Co-ordination with Manufacturing, Production, Stores, Quality Control, Engineering and Quality Assurance for conducting necessary trials for Technology Transfer Projects.
* Review of MFC/BMR/BPR/PVP/MFR, finalize sampling quantity and define CPPs & CQAs for strengthening the documents before execution and to review the executed documents after the batch.
* Sending of all Submission Documents of R&D ANDAs and other products in coordination with QA, QC and production.
* Support in handling of Deviations/OOS/Failures observed during execution of technology transfer projects
Male candidates will be prepared
Candidates wish to relocate Goa can apply.