Sr Research Associate, Technical Services

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.