About the role
Job Description Summary
Senior Technical Services associate for handling of technology transfer activities of execution, documentation, filing support and other activities as responsible.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.