Commissioning & Qualification Lead
il y a 2 semaines
About the role:
The C&Q Lead manages resources and coordinates commissioning and qualification activities related to strategic projects from basic design to implementation.
Main responsibilities are the following:
- Act as the C&Q representative for strategic projects, from basic design to implementation phase.
- Manage the project validation team and project deliverables.
- Work in close collaboration with the Project Manager, Engineering, Operations and Quality Representatives.
- Define and ensure deployment of C&Q strategy in alignment with global procedures.
- Ensure that all equipment & rooms are validated and in an accurate validation state.
- The first mission will consist of leading C&Q for the new stateoftheart purification building.
How you will contribute:
- Lead the planning, execution, and documentation of commissioning and qualification activities for new facilities, equipment, and systems.
- Ensure coordination of C&Q activities and achievement of agreed milestones.
- Create and update the C&Q governing documents as necessary.
- Manage C&Q partners for all activities being into their scope.
- Ensure that all C&Q issues, across all disciplines, are addressed through all phases of the Project Life Cycle.
- Monitor and report progress through project management and dashboards tools for C&Q activities.
- Perform the final handover to the routine validation team.
- Identify potential risks associated with commissioning and qualification activities and develop mitigation plans.
- Conduct risk assessments and implement controls to minimize risks related to quality and safety.
- Provide leadership and direction to the team.
- Define roles, responsibilities and performance expectations for team members, fostering a culture of accountability and collaboration.
- Hiring/coordination of internal/contractors.
- Mentor and coach team members, supporting their professional development and growth within the organization.
- Allocate resources effectively and prioritize tasks to optimize team productivity and project outcomes.
- Foster a positive work environment that encourages innovation, creativity and continuous improvement.
- Partner with and report to the Project Manager during all project phases.
- Communicate project status, milestones and issues to key stakeholders, facilitating alignment and decisionmaking.
- Closely collaborate with Engineering, Operations and Quality Representatives.
- Participate in the preparation & execution of GMP inspections / submissions.
What you bring to Takeda?:
- Industrial, Chemistry or Life Science Engineer.
- Significant experience (~7 years) in commissioning, qualification and validation within the pharmaceutical industry, preferably in a leadership role.
- Strong project management skills, including ability to plan, organize and execute complex projects on time and within budget.
- Proficiency in risk assessment methodologies and tools, with experience in identifying and mitigating risks associated with commissioning and qualification activities.
- Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
- Good documentation and report writing skills, with keen attention to detail and accuracy.
- Fluent in French and English (both written and spoken).
- Leadership skills.
- Collaborative mindset, ability to work effectively in a matrixed organization.
- Innovation. Lead benchmarks and innovative ideas. Propose and deploy innovation plans.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. _At Takeda, we embrace diversity as a whole._
Locations:
BEL - Lessines
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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