Job Description Summary

Job Description

Primary Responsibilities: 
Co-ordination, Communication and Smooth Execution for Technology Transfer Activities:
a)    Co-ordination, Communication for the Technology Transfer of Submission, 
       Site transfer, Validation and lifecycle management of products.
b)    Evaluation, preparation, optimization and finalizing the documents & process for 
       successful execution and implementation at site.
c)    Aligning the team members and CFT’s to achieve organizational goals through 
       discussion to meet the timelines.
d)    Participating in updating the project details in daily, weekly and monthly meetings.
e)    Risk evaluation and gap analysis of projects & finalizing the batch sizes to initiate the
       procurement of prerequisites before commencement of project at site.

f)     Preparation, review and approval of engineering, submission and validation batch  
       documents and preparation and participating in gate meeting and project discussions.
g)    Monitoring of engineering, submission and validation batches as per the timelines 
       and market requirement.
h)    Preparation of placebo and submitting the same to QC for testing as per project         
       requirement.
i)     Support for regulatory filings for the required documentation.
j)     Handling of investigations to make quality documentation and to suggest the way
       forward .
k)    Handling of CMC queries to get the product approval on time and to make readiness 
       for on time launch.
l)     Commercial support throughout the product lifecycle management.

Other Activities.

a)    Audit compliance.
b)    Ensuring cGMP at site level.
c)    Risk evaluation for Nitrosamine impurities.
d)    Following and implementing the organization values during day-to-day activities.

Secondary Responsibilities: 

a) Awareness of EHS policy, significant environment aspect & impacts associated with workplace and contribution to environment management system.
b)Supporting to the cross functional team during Audit and performing internal Audits (Qualified auditor).
c)Responsible to follow and ensure the procedures pertaining to the environmental management system.
d)Responsible to keep the workplace neat and clean.