European C&Q Lead - Europe

Description

Our World-leading Pharmaceutical client has an exciting opportunity for a European C&Q Lead, to provide support to a number of C&Q Projects based across Europe

Reporting to the Global Director of Commissioning & Qualification, you will be responsible for Commissioning and Qualification support in the respective regional capital projects.

Working on a number of existing projects, you will be providing C&Q expertise from a strategic level, supporting the C&Q strategy development, procedures and practices reviews, ensuring in line with compliance and regulatory guidelines.

This will involve contributing to the C&Q planning process and to support the team during the execution stage on an as-needed basis as a C&Q auditor to ensure compliance.

RESPONSIBILITIES WILL INCLUDE:

To evaluate current projects - what needs changing, provide expertise
Interface with the capital projects' regional teams to support develop the C&Q strategy and methodology
Support the C&Q team, developing the risk assessment studies, test matrices, and verification protocols
Provide training to capital project teams on C&Q, GMP, GDP, GEP, and C&Q safety
Provide periodical status reports to Director, Global C&Q regarding the regional projects' status
Provide direct support to the Director of Commissioning & Qualification as needed to conduct studies, assessments, and evaluations related to C&Q

To be successful for this role we are looking for the following skills & experience:

• Minimum University degree in Engineering / Scientific field
• Minimum of fifteen (15) years of hands on experience in C&Q planning and execution.
• Experience in C&Q of pharmaceutical facilities and aseptic processes is an asset.
• Experience with current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology is a must have.
• Knowledge of regulatory requirements relevant to pharmaceutical facilities.
• High level of familiarity with Excel, Word, Access, and Microsoft Project.
• Strong time management and project management skills.
• Ability to work in a fast-paced environment and to travel within the region on short notice.
• Excellent oral and written communication skills in English.
• Customer service orientated.
• This individual should be a self-starter with strong interpersonal, organisational, and technical skills. Capability to work both independently and in a team environment.
• Strong analytical skills required.
• Must be able to establish strong working relationships with stakeholders (project management, quality, operation, system owner and tech. transfer) to ensure high quality deliverables meeting cGMP and site quality requirements

Call me today to discuss this exciting opportunity!