Over de functie
About the role
As a Project Manager at Fagron Sterile Services, you will play a crucial role in supporting the planning, coordination, and execution of capital projects with a strong focus on maintaining compliance with current Good Manufacturing Practices (cGMP). You will work closely with the engineering team to ensure projects are delivered on time, within budget, and in accordance with cGMP guidelines. This role offers an excellent opportunity to develop your project management skills in a dynamic and fast-paced environment.
• Project Support: Developing and maintaining project plans, schedules, and budgets. Coordinate project activities and tasks, ensuring alignment with project objectives and cGMP requirements.
• cGMP Compliance: Collaborate with cross-functional teams to ensure compliance with cGMP regulations throughout project execution. Review project documentation, procedures, and specifications to ensure adherence to cGMP guidelines.
• Communication: Facilitate effective communication between project stakeholders, team members, and external partners. Prepare and distribute project status reports, meeting minutes, and other project-related documentation.
• Documentation Management: Maintain project documentation, including project charters, risk registers, change control logs, and other project-related records. Ensure proper version control and adherence to document control procedures.
• Quality Assurance: Support quality assurance activities, such as document reviews, inspections, and audits, to verify compliance with cGMP requirements. Assist in the implementation of corrective actions and preventive measures to address quality issues.
• Risk Management: Assist in identifying and evaluating project risks and developing risk mitigation strategies. Monitor and track project risks, escalating issues as necessary and supporting the implementation of risk mitigation plans.
• Supplier Coordination: Coordinate with external suppliers, contractors, and vendors to ensure timely delivery of goods and services in compliance with cGMP regulations. Assist in supplier selection, contract negotiation, and performance evaluation.
• Project Reporting: Contribute to the preparation of project status reports, progress updates, and presentations for project stakeholders. Assist in analyzing project performance data and identifying areas for improvement.
• Change Management: Support the change management process, including assessing change requests, evaluating impacts on project scope, schedule, and budget, and assisting in the implementation of approved changes.
• Continuous Improvement: Contribute to process improvement initiatives, identifying opportunities to streamline project management processes and enhance efficiency.
Maak het verschil
• Bachelor's degree in a relevant field (e.g., engineering, project management, life sciences).
• 2 years of experience in a project management role, preferably in a cGMP-regulated environment.
• Familiarity with cGMP regulations and their application to capital projects.
• Strong organizational and time management skills, with the ability to handle multiple tasks and priorities simultaneously.
• Proficiency in project management software and tools.
• Demonstrate reliability in attendance and punctuality.
• Self-motivated and customer centric.
• Experience with Microsoft applications (Outlook, Excel, Word)
• Attention to Detail: Meticulous approach to reviewing project documentation, ensuring accuracy and compliance with cGMP guidelines.
• Communication: Excellent verbal and written communication skills, with the ability to effectively convey information to stakeholders at all levels.
• Teamwork: Collaborative mindset and ability to work effectively in cross-functional teams to achieve project goals.
• Problem Solving: Strong analytical and problem-solving skills, with the ability to identify and address project issues in a timely manner.
• Adaptability: Flexible and adaptable approach to changing project requirements and priorities.
• Initiative: Proactive and self-motivated attitude, with a willingness to take ownership of tasks and drive them to completion.
• Technical Aptitude: Ability to understand technical concepts related to cGMP compliance and apply them to project execution.
Wat bieden wij?
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success.
Our benefits include, but are not limited to:
• Competitive Salary
• Health, Vision, and Dental Insurance
• Company Paid Life Insurance
• Generous Paid Holidays
• Paid Volunteer Time
• Generous Paid Time Off and Rollover
• Company matching 401K and Retirement Savings Plans
• Employee Assistance Program
• Flexible working arrangements