Project Lead

Position Summary

Principal Responsibilities

1.    Develop comprehensive project plans outlining re-validation objectives, timelines, resource requirements, and risk management strategies.
2.    Coordinate with internal stakeholders, including manufacturing, quality assurance, regulatory affairs, and engineering teams, to define project scope and deliverables.
3.    Execute project plans, monitor progress, and proactively identify and address any issues or deviations from established goals.
4.    Ensure all re-validation activities comply with relevant regulatory standards, including FDA regulations (e.g., 21 CFR Part 820) and international quality standards (e.g., ISO 13485).
5.    Maintain a thorough understanding of regulatory requirements related to process re-validation in the medical device industry and integrate them into project planning and execution.
6.    Foster effective communication and collaboration among cross-functional teams involved in re-validation projects.
7.    Facilitate regular project meetings, provide updates on project status, and solicit input from team members to drive project success.
8.    Act as a liaison between internal stakeholders and external partners/vendors as needed to support project objectives. 
9.    Ensure accurate and comprehensive documentation of all re-validation activities, including protocols, reports, and other relevant documentation. 
10.    Identify opportunities for process improvements and efficiencies in re-validation procedures, documentation practices, and project management methodologies.
11.    Implement best practices and lessons learned from previous re-validation projects to enhance future project outcomes.
 

Education / Experience Requirements

Qualification : 
Bachelor's degree in engineering, life sciences, or related field.
            
Experience : 
Proven experience (7-10 years) in project management within the medical device    or pharmaceutical industry, with a focus on process validation or re-validation.

Specialized Skills / Other Requirements

Other Competencies/Skills :    
-Strong understanding of regulatory requirements and quality standards                                                                                                      to medical device manufacturing (e.g., FDA QSR, ISO 13485)s
-Excellent communication, leadership, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. 
-Proficient in Microsoft Office applications and data analysis software
Productivity and Problem-Solving Technique.
-PMP certification or equivalent project management credentials preferred
-Ability to work well in a team environment and collaborate across departments
-Proactive to learn and highly organized with a keen attention to detail and the ability to prioritize and manage multiple projects simultaneously