Sr Executive II, Project Mgmt R&D-ARPL-PMRD AR

Job Summary

Responsible for leading Supplier Driven changes (SDC) Projects At ARPL, New Supplier Qualification (NSQ) Projects for NPD (New Product Development)/Product Life Cycle Management (PLCM) related to active pharmaceutical ingredients (APIs) and excipients. Also work directly with the appropriate functional groups within Apotex, external manufacturers, including Apotex Pharmacies Group companies, on SDC (commercial and new product development) and new source qualification related to active pharmaceutical ingredients (APIs) and excipients.

Job Responsibilities

• Initiate Change Controls in QMS Track Wise for Supplier Driven changes impacting New Product Launch and commercial APIs.
• Lead cross-functional Global API Projects Changes and initiatives, serving as the project lead and primary contact for assigned projects at Apotex, throughout the development of project plans to successful project completion within the required timelines
• Demonstrate technical expertise to explain the API related issues to any technical, quality or regulatory teams and drive the discussion in conclusive manner.
• Make sound technical decisions based on review of internal/external complex technical reports, interpret the data/issues, participate in complex API related investigations and support deficiency responses related to regulatory submission.
• Facilitate and drive the supplier driven changes and NSQ projects from the receipt of the changes till closure of CCRs through track-wise system.
• Demonstrate developed project management skills by utilizing the tools, systems, methodologies and software to lead, plan, manage and execute all Global API related projects, changes and / or initiatives.
• Understand time-sensitive nature of managing changes by minimizing and/or eliminating delays within the critical path. Work with all functional areas to manage project risk by allocating task and decision-making responsibilities to appropriate team members. Ensure all plans and scheduled tasks are on target to achieve project success.
• Lead and facilitate with cross functional teams and ensure that prioritization of proposed changes is completed.
• Facilitate and participate in cross-functional discussions and meetings to understand the scope/risk of a change, engage stakeholders.
• Participate in Global API meetings to assess cross-functional impact of changes and define implementation plans/strategies. Ensure the context of the change is understood as it relates to the current scope of the project.
• Facilitate the activities for addition of new source evaluation for API supplier at Apotex. Sourcing, Analytical and technical evaluation, Regulatory strategy and project management from Start to End.
• Support the establishment of a communication framework to inform stakeholders of the progress, issues and proposed contingency plans. Escalate issues as appropriate.
• Identify needs and implement improvements for Global API processes and participate in the regular review and revision of existing SOPs to ensure accuracy and compliance.
• Preparation of reports and presentations for senior management review.
• Lead by example, demonstrating the values of Collaboration, Courage, Perseverance and Passion to positively influence the shift towards a Quality Culture.
• Perform all duties and responsibilities in accordance with established GMP/cGMP operating procedures and safety standards.
• Perform additional duties as required.

Job Requirements

• Education
  • Minimum bachelor s degree M pharma
• Experience
  • Minimum 5 Years of experience in Pharmaceutical Industry
• Knowledge, Skills and Abilities
  • Having knowledge in QMS.
  • Having knowledge of Project management.
  • Having knowledge in Quality Systems, Regulatory Affairs
  • Having good interpersonal and communicational skills.
  • Hands on experience in Track wise application, SAP, MS Office etc.
  • Strives to drive projects effectively.

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