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Qualification Validation Lead

ROLE OVERVIEW

An exciting opportunity has arisen for a Senior CQV Coordinator to join a leading pharmaceutical company during a critical phase of their expansion project. Our client is adding a new production line within an existing facility, aiming for a site restart scheduled for early 2027. This role offers a unique chance to coordinate key qualification and validation activities, ensuring smooth project progression within tight deadlines and across diverse stakeholder groups.

This position is ideal for a seasoned professional with proven experience in qualification and validation, who is adept at managing multiple teams and complex projects in a high-stakes environment. Based remotely with significant on-site activity, you will play a pivotal role in supporting a successful site restart, working closely with internal teams, external consultants, and suppliers.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Senior CQV Coordinator will be varied; however, the key duties and responsibilities are as follows:

    • Coordinate all qualification and validation activities to ensure adherence to project timelines and quality standards.
    • Follow-up on planning activities, working in collaboration with planners to ensure prerequisites are met prior to execution.
    • Monitor progress through KPIs and reporting, providing visibility on project status and potential risks.
    • Anticipate and address risks or blocking points proactively to maintain project momentum.
    • As the CQV lead, you will liaise with engineers, internal teams, external stakeholders, and suppliers to ensure seamless coordination.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Senior CQV Coordinator, we are looking to identify the following on your profile and past history:

    • A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
    • Strong proven experience (8+ years) in qualification & validation within a regulated environment, with demonstrated project coordination skills.
    • Ability to understand CQV processes, anticipate activities, and structure workflows effectively.
    • Excellent communication skills in French and good English writing skills for reporting purposes.
    • Experience managing stakeholder relationships and working in complex, multi-package projects.

WHAT’S IN IT FOR YOU?

Joining our client offers a rich opportunity to work on a high-profile project within the pharmaceutical industry, with meaningful involvement in critical qualification activities. You will develop your stakeholder management skills and play a key role in enabling a key site restart, all within a collaborative and innovative environment. The role promises a dynamic workload with on-site presence during peak phases, offering hands-on experience in a fast-paced setting.

Key Words: qualification / validation / CQV / project management / stakeholder management / pharmaceutical / regulatory environment / on-site presence / coordination / multi-stakeholder / risk management / reporting

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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