Beschreibung
Validation Project Manager (Freelance)
Cologne
18-month contract
€100 per hour
Optimus Life Sciences is an internationally recognized pharmaceutical company in Cologne that is looking to recruit an experienced validation specialist on an 18-month contract.
The role requires a solid technical understanding of Validation processes and protocols but, will focus more on the oversight and management of these activities. Applicants must have experience leading small teams, as well as delivering projects on an agreed time schedule.
Responsibilities
- Apply the validation processes, SOPs and templates at Maidenhead site to ensure any change which requires validation is proven as robust and meets the intention of the change.
- Represent the quality function in project teams (eg Engineering/IT/NPI projects) ensuring changes with the potential to impact product quality are identified and managed in line with the appropriate validation processes.
- Responsible for delivering assigned validation projects of the site validation master plan (equipment, process, cleaning, computer systems, analytical equipment and methods, revalidation etc).
- Subject matter expert for validation during internal/external audits and sharing expertise across site through training and workshops.
- Carry out periodic revalidation activities: assess the cumulative impact of change to identify adverse trends, identifying risks and developing action plans.
- Ensure that GMP, quality, health & safety are considered in all aspects of the role and across the department.
- Support the development of effective knowledge and document management within the department processes to increase visibility and awareness of validation on site.
Requirements
- Computer literate, with solid technical skills and the ability to quickly learn new applications.
- Strong on personal initiative 'flexible thinking' and drive.
- Must be a strong team player and effective team leader.
If you're interested in applying for this role, please send a CV to (see below) for more detail - thanks!