CQV Lead
CQV Lead
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description Summary
Are you ready to lead the charge in ensuring pharmaceutical excellence As a CQV Lead (Commissioning Qualification and Validation Lead) youll play a pivotal role in bringing cutting-edge facilities and processes to lifeoverseeing commissioning qualification and validation activities that ensure compliance safety and operational readiness. This is a high-impact position where youll collaborate with cross-functional teams shape quality strategies and drive GMP standards from concept to execution. If youre passionate about delivering robust validated systems in a regulated environment and want to be at the forefront of innovation this is your opportunity to make a lasting difference.Reporting to Capital Projects Director.
The CQV Lead role will lead and coordinate the CQV project activities in line with the site procedures. The CQV Lead will work across all project functions including EHS Quality Operations Finance Operations Process Engineering Operational Engineering Logistics Lean & Digital to understand their functional requirements and develop and execute the optimum validation strategy.
Job Description
Responsibilities:
Lead and coordinate CQV projects ensuring timely execution and compliance with industry regulations.
Support the transition to a digitized C&Q platform.
Ensure effective resource planning is established and managed throughout the project in line with schedule and associated CQV budget including the management of CQV personnel.
Engage at charter stage of projects to ensure proposed project schedule has been reviewed
Manage and coordinate equipment qualification lifecycle activities including but not limited to Factory Acceptance Testing (FAT) SAT DQ Installation -Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
Develop and maintain project plans schedules and budgets to ensure alignment with business objectives.
Manage and coordinate all CQV documentation to support CQV activities
Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
Ensure that all stakeholders including client teams vendors and subcontractors adhere to established project protocols.
Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
Qualifications and Requirements
Experience of managing teams or projects in a fast paced and complex environment.
Relevant qualification (Degree) and strong experience in pharmaceutical industry commissioning and qualifying GXP systems.
Experience in the deployment and/or extensive working knowledge/ experience of a digitized C&Q platform.
Significant project lifecycle experience in delivering CQV for Capex projects
Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
Excellent verbal and written communication skills Experience in developing a strong working relationship with other departments. Experience in presenting validation reports in quality inspections.
Strong analytical problem-solving skills strategic decision maker effective planner and ability to communicate effectively.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
#LI-BG1
#LI-onsite
Additional Information
Relocation Assistance Provided: No
Employment Type
Full-Time
