Our Cork based Pharma Client is currently looking to fill a number of C & Q Engineering roles
Duties will include:
- Provide governance & guidance on validation deliverables, in line with Site SOP’s, Good Manufacturing Practices (cGMP’s) and all other regulatory requirements, to the project.
- Dedicated Validation review/approver on cleaning validation lifecycle documentation
- Manage project validation team to deliver to project commissioning timelines
- Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel
- Document generation & vendor documentation review during design development stage – pre-commissioning
- Resolves validation issues and deviations with limited direct supervision
- Maintain all documentation pertaining to the project validation.
- As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies
- Provide day-to-day guidance and training to validation engineers.
- Resilient profile with the ability to deliver in an dynamic environment
- Ability to engage and manage multiple stakeholders and cross-functional team to achieve the project objectives
- Operationally excellent
- Organised with systematic approach to prioritisation
- Dedicated and focused on project delivery
Knowledge, Experience and Skills:
- Proven track record in role of Validation/ C & Q Engineer– minimum 5 years’ experience in Pharma/Bio/Med Device
- Experience of working in GMP environment & management of project Validation lifecycle
If you are interested, please send your CV in confidence to [email protected]