Validation Project Manager
- North America, East Coast
- Contract
- Commissioning, Qualification and Validation
Our client, a global pharmaceutical manufacturing organization are looking for a talented Validation Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Responsibilities:
- Oversee & manage validation projects/ time-lines from initiation to completion.
- Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
- Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
- Develop schedules / project plans / meeting minutes. Provide updates as needed.
- Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.
- Coordinate resources and personnel to achieve company and department goals.
- Pre-approve and post-approve qualification protocols.
- Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.
- Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
- Execute validation protocols (as needed).
- Prepares validation master plans for facilities, equipment, and systems.
- Approves the resolution of discrepancies encountered during protocol execution.
- Proven success in managing, reviewing, authoring, and approving full life-cycle technical documentation.
- Experienced generating and executing validation activities on a range of equipment and systems.
- Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
- Experienced in vendor coordination.
- Excellent technical writing skills.
- Strong understanding of industry regulations and requirements.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- Working knowledge of Microsoft Office products (Project, Outlook, Word, Excel, PowerPoint).
- Bachelor’s Degree preferably in Engineering or Life Sciences
- cGMP Experience
#LI-NR1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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I manage this role.