What are the responsibilities and job description for the project manager(medical device) position at TekOne IT Services Pvt. Ltd.?
Poistion-PROJECT MANAGER
Location-MURRYSVILLE, PA
Job Description
Location-MURRYSVILLE, PA
Job Description
- Develop and execute a detailed project plan for the transfer of the manufacturing line while adhering to regulatory and compliance requirements specific to the medical products industry.
- Coordinate with cross-functional teams including engineering, quality control, regulatory affairs, and operations to ensure a seamless and compliant transfer process.
- Manage the timeline, budget, and resources for the manufacturing line transfer while maintaining a focus on quality.
- Identify and mitigate any potential risks or issues that may impact the transfer process and implement strategies to minimize disruption to ongoing operations.
- Ensure that the transfer activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards for medical product manufacturing.
- Collaborate with supply chain and logistics teams to oversee the movement of equipment, materials, and products during the transfer process.
- Provide regular updates to key stakeholders and leadership on the progress of the manufacturing line transfer and addressing any concerns or challenges that arise.
- Conduct thorough validation and testing of the transferred manufacturing line to ensure it meets all necessary requirements for producing high-quality medical products.
- Document all transfer activities and ensuring that the new manufacturing line setup is fully documented and in compliance with all relevant standards and regulations.
- Lead and support the project team to ensure effective communication, collaboration, and successful execution of the manufacturing line transfer activities.
- Effective communication, leadership, and problem-solving skills
- Excellent in project management skills, and experience in medical product manufacturing and its dependent operations
- BS/BA degree in Management, Operations, Engineering or closely related field and PMP certification as an added advantage
