Torrent Pharma - job opening For PDG (Project Development Group)

Job description

**Job Summary: Product Development & Site Execution Lead R&D** This role ensures seamless execution of pharmaceutical product development from feasibility to dossier submission, while coordinating cross-functional teams and regulatory compliance. **KEY RESULT AREAS/PRIMARY ACTIVITIES WITH PERFORMANCE INDICATORS** *Main activities or responsibilities of the job and the end result the job is expected to achieve.* **Development** - To ensure feasibility analysis of New Product Proposal with respect to manpower, materials, machinery and cost - To prepare product budget i.e. considering commercial, development and technical feasibility - To decide project timelines and publish it in EPM and monitor it throughout the project - To ensure various clearances and certifications from Regulatory bodies and other agencies for development projects - To coordinate with Purchase Dept. and ensure procurement of API, KSM, Excipients, consumables standards, impurity, column and International Finished Formulation IFF - To minimize bottlenecks by timely intervention so as to ensure smooth and timely lab scale development - To finalize CRO on the basis of cost comparison, criticality and method availability criteria for Pilot Bio and Pivotal Bio - To ensure effective run of EPMS i.e., tracking man-hours and updating completion of project activities - To prepare months MIS of total budget and Project Status to be presented to Business Head - To conduct Product Extension feasibility analysis in other markets w.r.t regulatory guidelines, exhibit batch, bio point of view etc. - To assist in variance analysis of monthly MIS from commercial - To present product development status to team members and business heads during monthly and quarterly project reviews respectively - To ensure timely submission of all dossiers from Quality department - To handle regulatory queries and timely address the same - To conduct project reviews development phase wise (Literature review, Strategy Review – Review 0, Review 1, 2, 3 and 4; both API & Formulation) - To coordinate with Plant, marketing, Finance and other departments to do costing of formulation & API for launch year and current year. **Site PDG** - To ensure timely pilot bio batch plan to PPC and budget the manufacturing load in PDL, EBA & commercial area. - To ensure proper monthly Exhibit batch / Scale up / FnD Trial / Optimization batch plan to plant PPC based on Priority/readiness for execution. - To ensure slot availability timely completion of the plan. - To ensure availability of all the plant documents i.e. BMR, PVP, Hold time protocol, BPR, Stability protocols, Form 32 site approval, etc as per Exhibit batch execution plan. - To ensure proper planning and prioritizing the cleaning validation (CV) / Analytical method validations (AMV) /Verifications (AMVe) for Finish Product/API/Excipients in co-ordination with plant QC and facilitate availability of all pre-requisites i.e samples, Impurity/column/instrument, etc. for timely completion of validation/verification activities. - To ensure proper planning, tracking and facilitating the execution of Exhibit batches and ensuring timely stability loading with due co-ordination with PPC/FFT/Production/QA/QC/RM store/PKG for various functions like Manufacturing PO, Pkg PO, dispensing, exhibit sample testing & release, Batch records release, packing planning, Stability loading, etc. - To ensure proper co-ordination with Plant QC to plan and prioritize Exhibit batch samples, Raw material and packing material testing and release - To ensure proper co-ordination and handling plant related activities to timely address Regulatory Queries like Analytical method validation (AMV) /verification (AMVe) / transfer (AMT), API/FP/Excipient CoA generation, Pharmacopeia updation, Plant document revision, Stability data availability, ongoing stability sample arrangement, etc in co-ordination with PPC/FFT-TR/QC/QA/RM store - To ensure proper closure of OOS/Deviations observed in Exhibit batches in co-ordination with all stake holders - To ensure plant documents availability for timely Dossier submission**Role & responsibilities** **Preferred candidate profile**