Posted today
DoE Q or L
Unspecified
Unspecified
Management
Cincinnati, OH (On-Site/Office)
This is an onsite position.
Purpose:
Overall management of the commissioning and qualification phase of FUE (facility, utility, and equipment) of a new packaging line program at the client's site in Cincinnati, Ohio. Work with site core functional teams on integrated schedules, resourcing management, and C&Q execution. Manage (and onboard where required) C&Q subject matter experts and the entire C&Q lifecycle in an efficient manner.
Responsibilities:
• Planning and coordination of C&Q activities in line with the client SOPs.
• Deliver program updates to both senior management and senior leadership as required.
• Onboard and Manage a C&Q team to deliver this key program for the client.
• Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
• Responsibility for meeting customer requirements and the necessary regulatory requirements as defined by FDA, EU and regional Ministries of Health as relevant.
• Drive risk assessments ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle.
• Participate in team meetings and workshops as required.
• Generate, Execute, review and approve documentation as necessary ensuring project documentation is of the highest standard.
Qualifications:
• Degree in an Engineering, Science or Computer Science discipline
• 10 Years' experience in a pharmaceutical / Medical device background.
• Knowledge of Pharmaceutical Regulatory Requirements and expectations
• Knowledge of a wide range of C&Q disciplines including Utility, Facility & Equipment qualification.
• Self-directed, self-motivated with an ability to represent the C&Q function in a high paced project environment
• Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Must have previous experience in a project management role. Management of contract staff in a previous role is beneficial.
Purpose:
Overall management of the commissioning and qualification phase of FUE (facility, utility, and equipment) of a new packaging line program at the client's site in Cincinnati, Ohio. Work with site core functional teams on integrated schedules, resourcing management, and C&Q execution. Manage (and onboard where required) C&Q subject matter experts and the entire C&Q lifecycle in an efficient manner.
Responsibilities:
• Planning and coordination of C&Q activities in line with the client SOPs.
• Deliver program updates to both senior management and senior leadership as required.
• Onboard and Manage a C&Q team to deliver this key program for the client.
• Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
• Responsibility for meeting customer requirements and the necessary regulatory requirements as defined by FDA, EU and regional Ministries of Health as relevant.
• Drive risk assessments ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle.
• Participate in team meetings and workshops as required.
• Generate, Execute, review and approve documentation as necessary ensuring project documentation is of the highest standard.
Qualifications:
• Degree in an Engineering, Science or Computer Science discipline
• 10 Years' experience in a pharmaceutical / Medical device background.
• Knowledge of Pharmaceutical Regulatory Requirements and expectations
• Knowledge of a wide range of C&Q disciplines including Utility, Facility & Equipment qualification.
• Self-directed, self-motivated with an ability to represent the C&Q function in a high paced project environment
• Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Must have previous experience in a project management role. Management of contract staff in a previous role is beneficial.
group id: TAYLOR
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