05 Nov
|
Apitoria Pharma
|
Hyderabad
05 Nov
Apitoria Pharma
Hyderabad
Job Purpose:
To drive and coordinate end-to-end procurement-related activities for Current Product Development (NPD), Cost Improvement Projects (CIP), MSAT projects and Alternate Vendor Development (AVD), ensuring timely availability, qualification and approval of raw materials required for product development, plant validation, commercialization and regulatory filings.
The Project Manager will serve as the central coordination point between R&D;, CRD, ARD, Strategic Procurement, Quality, Vendor Qualification, Regulatory Affairs, MSAT, SCM and manufacturing plants to ensure disciplined project execution.
Roles & responsibilities:
NPD, CIP and MSAT CIP Projects
2.1 Sample Procurement and ROS Finalization
- Coordinate with the purchase team to ensure timely procurement and supply of raw material samples.
- Ensure collection of required vendor documents in accordance with the approved checklist.
- Coordinate with CRD, RAD and SCM teams for finalization of Raw Material Details (RMD) and Raw Material & Operating Specifications (ROS) for APIs.
2.2 Specification Finalization and Vendor Approval
- Coordinate with CRD, ARD and Strategic Procurement for finalization of raw material specifications.
- Ensure availability of approved specifications and Analytical Test Reports (ATR) for all raw materials included in the RMD.
2.3 Vendor Qualification and Linkup
- Track vendor qualification and approval status and drive timely completion of vendor linkup activities in the relevant systems.
2.4 Raw Material Supply for Plant Validation
- Obtain raw material delivery schedules against purchase requisitions from the purchase team.
- Track receipt, sampling, testing and approval of raw materials.
- Drive raw material approval within the target timeline of 10 days from delivery, subject to completion of required quality testing.
- Coordinate with the Project Management and manufacturing teams to confirm plant validation schedules.
- Ensure all required raw materials are available before commencement of validation batches.
2.5Technical and Regulatory Evaluation
- Coordinate MSAT evaluation and technical suitability assessment.
- Ensure completion of Potential Genotoxic Impurity (PGI) and nitrosamine risk evaluations, wherever applicable.
- Coordinate required documentation and technical assessments for vendor qualification.
3. Cross-Functional Coordination and Governance
- Act as the single-point coordinator for procurement-related project execution.
- Conduct periodic review meetings with R&D;, CRD, ARD, QA, VQ, Regulatory Affairs, MSAT, SCM and manufacturing teams.
- Establish project timelines, milestones, deliverables and responsibility matrices.
- Identify delays, dependencies and bottlenecks; drive resolution with relevant stakeholders.
- Escalate critical issues affecting project timelines to the Head Strategic Procurement.
- Maintain updated project trackers, risk registers and periodic management reports.
4. Key Deliverables
- Timely sample availability for NPD, CIP and MSAT projects.
- finalization of RMD, ROS and raw material specifications within agreed timelines.
- Completion of vendor qualification, approval and vendor linkup.
- Timely availability and approval of raw materials for plant validation.
- Successful execution and closure of alternate vendor development projects.
- Completion of technical, quality and regulatory assessments.
- Timely submission and tracking of required regulatory filings.
- Improved project execution timelines and reduction of procurement-related delays.
Preferred candidate profile:
- M.Sc in Chemistry background preferable or related Chemistry qualification is preferable.
- Pharma experience in strategic sourcing/ procurement, Vendor development or NDP, Project Coordination.
- Strong cross-functional coordination, tracking skills.
- Exposure to RMD/ ROS, Vendor qualification is a plus.
📌 Strategic Sourcing & Project Management (NDP/ AVD) (Hyderabad)
🏢 Apitoria Pharma
📍 Hyderabad