We are seeking for an experienced Project Manager to oversee the design, Construction and Commissioning of our new in-vitro diagnostics (IVD) manufacturing facility.
The Project Manager will be responsible for the day-to-day execution of projects conducted within the facility of Ash Biomedical Diagnostics Limited and must be competent in the managing of scope, schedule, finance, risk, quality, and resources.
Key Responsibilities:
Develop, maintain, and update the Project Documents, ensuring alignment with the company's objectives and compliance with ISO 13485:2016 and ISO 14971:2019 standards.
Create and execute a detailed project plan, including defining the project scope, objectives, deliverables, and resources required involving all relevant stakeholders and ensuring technical feasibility.
Develop workflow policies and procedures that improves efficiency without compromising safety or quality.
Coordinate internal resources and third parties / vendors for the flawless execution of projects.
Coordinate and manage cross-functional project teams, and external stakeholders such as architects, engineers, contractors, and regulatory authorities to ensure projects are delivered timely with desired results produced.
Ensure that projects are delivered timely within scope and budget.
Manage project risks including design / development of contingency plans.
Monitor overall progress and use of resources, initiating corrective action where
Ensure that the facility is designed, constructed, and commissioned in accordance with relevant local and international regulations, quality standards, and industry best practices.
Establish and maintain effective communication channels through agreed lines on project progress with all project stakeholders, providing regular status updates and managing stakeholder expectations.
Facilitate and oversee the procurement and installation of equipment, technologies, and systems for the IVD manufacturing facility.
Coordinate with relevant departments to ensure smooth integration of the new facility into existing operations, including supply chain, distribution, and quality management systems.
Establish resource requirements and develop a resource allocation plan.
Support the recruitment and training of skilled personnel to manage and operate the facility.
Conduct project evaluation review to assess how well the project was managed and measure the project performance.
Requirements:
M.Sc. or B.Sc. in Project Management, Engineering, or a related field with Professional certification such as PMP
At least 5 years of experience in Project management, preferably within the medical device, Pharmaceutical, or related industry.
Knowledge of relevant standards and regulations.
Proven experience in managing complex, large-scale projects involving cross-functional teams and multiple stakeholders.
Sound Technical Competence
Excellent communication, interpersonal, negotiation and leadership skills.
Strong analytical, problem-solving, and decision-making abilities.
Driven to deliver results with firm deadlines.
Proficiency in project management software and tools