Assistant Manager - Technology Transfer

Torrent Pharmaceuticals · Not specified · onsite · Posted 55d ago

Not disclosed9–14 yrsfulltimeSourced from Foundit

About a minute. You'll make an account on the way through.

About this role

Job description

Role & responsibilities:

To receive instruction from Manager / General Manager.
To follow proper Gowning / De-gowning procedures as per GMP and ensure that the same is followed by all the persons in the production area.
To keep superiors informed about all the developments within the department, abide by all SOP, company rules & regulations and company policies.
To issue guidelines and directives to sub-ordinates for scheduling the technology transfer activities.
To ensure preparation of technical package & documentation related to technology transfer as per GMP ®ulatory requirements.
To review documents of New Product and regularization of Old Products which includes preparation of QFR, BMR, ISP, PPQP, PPQR, ESR (Exhibit, Engineering & site shift exhibit), and MFC etc.
To review GAP analysis received from Technology sending and receiving team.
To review knowledge sharing presentation of site shift products that includes Product history, critical process parameters, critical quality attributes, trend data of granulometry, equipment equivalency evaluation, market complaint details and stability results trend analysis data.
To coordinate with QA, QC, Production, SCM & PPC and discuss details about site shift products to sending and receiving locations.
To verify the various in-process checks as mentioned in the BMR and record the data on line in BMR.
To maintain the quality systems during Technology Transfer activity so as to comply any regulatory audits without non-compliance.
To co-ordinate with TRC related for the New Product Development, regarding technology receipt, it's planning and final execution of the product.
To coordinate with technology receiving and sending team and ensure for availability of resources and documents for product transfer and to evaluate the technical requirement of equipment & instrument to be procured at locations.
To execute and follow up of Engineering Batch / Optimization Batch / Validation Batch at site shift location.
To understand and follow all written procedures and manufacturing instructions mentioned in the respective batch record or any other quality documents or any other quality document before starting production activity.
To review Engineering Batch summary report / Exhibit Batch Summary Report / Validation summary report / PPQR with coordination of sending and receiving team.
To improve constantly the existing formulation, process and machinery in co-ordination with production and formulation development department.
To identify the areas where, there is possibility of improvement: (i) Process Improvement (ii) Productivity & Cost reduction (iii) Automation in manufacturing process like Product operation recipe etc.
To ensure that Quality, Health, Safety & Environment Policy and Energy Policy & Procedure are followed.
To motivate subordinates to ensure healthy spirit of teamwork at workplace with the help of Personnel Department.
To provide training to departmental employees regarding process and safety requirement and to ensure that the Quality, Health, Safety and Environment policy and procedures are followed.
To ensure that all SOP trainings are fulfilled on periodic basis for self as well as department.
To coordinate activities like visit, document transfer and monitoring (but not limited to) related to manufacturing of products at CMO site.
To carry out activities related to SAP.

Sourced from foundit

Skills

QASAPbmr writingSCMproductionQC

About Torrent Pharmaceuticals

Torrent Pharmaceuticals

Pharma

15.1k+

employees

1971

55 years old

Ahmedabad, Gujarat

India

About

Torrent Pharmaceuticals operates in the healthcare sector, focusing on innovative therapies in cardiology, CNS, and other medical segments, enhancing patient care globally.

Industries

Pharma

Employee ratings

3,071 reviews

4.0/ 5

Culture

4.0

Career growth

3.0

Work-life

4.1

Employees rate it well for

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Job description

Role & responsibilities:

To receive instruction from Manager / General Manager.

To follow proper Gowning / De-gowning procedures as per GMP and ensure that the same is followed by all the persons in the production area.

To keep superiors informed about all the developments within the department, abide by all SOP, company rules & regulations and company policies.

To issue guidelines and directives to sub-ordinates for scheduling the technology transfer activities.

To ensure preparation of technical package & documentation related to technology transfer as per GMP ®ulatory requirements.

To review documents of New Product and regularization of Old Products which includes preparation of QFR, BMR, ISP, PPQP, PPQR, ESR (Exhibit, Engineering & site shift exhibit), and MFC etc.

To review GAP analysis received from Technology sending and receiving team.

To review knowledge sharing presentation of site shift products that includes Product history, critical process parameters, critical quality attributes, trend data of granulometry, equipment equivalency evaluation, market complaint details and stability results trend analysis data.

To coordinate with QA, QC, Production, SCM & PPC and discuss details about site shift products to sending and receiving locations.

To verify the various in-process checks as mentioned in the BMR and record the data on line in BMR.

To maintain the quality systems during Technology Transfer activity so as to comply any regulatory audits without non-compliance.

To co-ordinate with TRC related for the New Product Development, regarding technology receipt, it's planning and final execution of the product.

To coordinate with technology receiving and sending team and ensure for availability of resources and documents for product transfer and to evaluate the technical requirement of equipment & instrument to be procured at locations.

To execute and follow up of Engineering Batch / Optimization Batch / Validation Batch at site shift location.

To understand and follow all written procedures and manufacturing instructions mentioned in the respective batch record or any other quality documents or any other quality document before starting production activity.

To review Engineering Batch summary report / Exhibit Batch Summary Report / Validation summary report / PPQR with coordination of sending and receiving team.

To improve constantly the existing formulation, process and machinery in co-ordination with production and formulation development department.

To identify the areas where, there is possibility of improvement: (i) Process Improvement (ii) Productivity & Cost reduction (iii) Automation in manufacturing process like Product operation recipe etc.

To ensure that Quality, Health, Safety & Environment Policy and Energy Policy & Procedure are followed.

To motivate subordinates to ensure healthy spirit of teamwork at workplace with the help of Personnel Department.

To provide training to departmental employees regarding process and safety requirement and to ensure that the Quality, Health, Safety and Environment policy and procedures are followed.

To ensure that all SOP trainings are fulfilled on periodic basis for self as well as department.

To coordinate activities like visit, document transfer and monitoring (but not limited to) related to manufacturing of products at CMO site.

To carry out activities related to SAP.