Job Description

Hi, 

We have vacancies in Technology Transfer department at Gland Pharma Ltd, Hyderabad, one of the leading Pharma company manufacturing injectables for global market.

Designation : Deputy Manager/Manager -Technology Transfer

Location : Hyderabad

Experience : 9 to 14 Years in Technology Transfer of injectables

Job Description : 

Facilitate the Technology transfer from R&D to manufacturing plant / Site Transfer.

Coordinate TT Activities across site functions with IPD cross functional teams and manufacturing unit team for successful execution of projects as assigned by technology transfer head.

For the successful new product Launch and implement the Execution Plan at the Site following activities to be performed/Ensured:

Gap Assessment

Plant Readiness Assessment / Execution

Batch Execution & Qualification

Appropriate Documentation & Records

Review and Assessment for QTPP, CQA CME, Trade dress, RA strategy.

Review of sterilizing grade filter validation documents.

Procurement of Raw material, Packaging material, Filters, silicon tubes and consumables with Co-ordination with R&D, SCM required for forthcoming projects.

To ensure availability of tooling, change parts, materials, equipments required for execution of new products feasibility/ assessment/ registration batches at unit.Initiation of Change controls for introduction of new product to facility.

Execution and monitoring of QbD batches for optimization of critical process parameter through Lab note book. On basis of Qbd batch results preparation of control strategy for Scale-up and Exhibit.

Review of sampling protocols for QbD and scale-up batches and compilation of scale-up reports.

Execution and monitoring Scale-up, Exhibit, and Process validation batches.

Designing and review of Master Formula card and Master Batch Manufacturing Records (BMR).

To coordinate with R&D/ F&D to passes all relevant quality product details, technical documents, regulatory requirements and logistic information to the receiving unit.

To ensure all required documents are provided to RA from unit QA on time for filing. Review and approve the Master documents required for the execution of new products transfer. Perform review and approval of change control for Feasibility, Assessment and Registration batches.

Compilation and review of Scale up Reports along with review of Executed LNB and analytical data.

Review of Process validation Protocols and Stability study protocols for Exhibit and commercial validation batches.

Coordination with QC and QA for Stability charging and review of stability data generated.

Preparation of Placebo batches for Q.C Analysis through Lab note book.

Compilation and review of Process Validation Reports along with review of Executed BMR

Support to prepare Control strategy, PV rationale, Hold time rationale for exhibit batches and commercial production.

To provide support in OOS/ OOT investigation for new products and site transfer/ commercial troubleshooting as and when required.

To ensure stability charging and review of stability data of registration batches on timely basis and to evaluate any risk associated with the product during stability. Also, to participate in retrospective QBD assessment as required.

Review of Product Development Report.

Handling of Regulatory query for ANDA filing products.

Review of cleaning validation reports, bulk sterilization reports and Equipment qualification reports.

Management of all process development documents and Lab Notebooks.

Initiation of request for SAP input data (BOM/Recipe) for exhibit and commercial batches.

Arrangement and Adequate availability of all relevant documents to QC, QA and RA leading to Technology transfer, regulatory filing and Product Launch.

Handling of SOPs, Change controls, Investigations and Deviations.

To assist the Plant/Manufacturing in conducting audit/inspections from various regulatory bodies and Audit compliance.