Encube Ethicals – Openings for Technology Transfer Department

Encube Ethicals – Openings for Technology Transfer Department

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!!!!!

  • Job Title : Senior Officer – Technology Transfer
  • Department : Technology Transfer
  • Experience : 2 – 7 Yrs.
  • Location : Ponda (Goa)

Job Description:

* 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

 

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