C & Q Lead
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| Job Type | Contractor |
| Area | Sligo |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3003 |
| Job Views | 687 |
- Description
- Team Horizon is seeking a C&Q Lead for our client who are a global leader in the biopharmaceutical industry. The role will be based at their site in the West of Ireland, and the successful candidate will be part of the Global Engineering team and be responsible for leading a team to deliver a number of complex programs on site. This role requires someone who has proven leadership capabilities.
What you will be doing:
Planning and coordination of C&Q activities in line with a risk-based approach (RBV).
Support concept design, detailed design development and planning.
Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
Standardize the C&Q approach across the network.
Assessment of third-party C&Q support and / or the assessment of individual candidates for specific project roles.
Manage C&Q teams / team coordinators to deliver key GE lead projects across the network.
Track project progress in line with agreed schedules week on week.
Support issue resolution through close working ties with the cross functional teams.
Support protocol execution and reporting activities when required.
Provide guidance and advisement to C&Q personnel.
International Travel to support C&Q execution and management of FAT’s as well as on site execution activities.
Assist with feasibility analysis such as cost / timeline estimations for new project proposals.
Work closely with key GE members and central services personnel to upskill.
Become proficient with global engineering standards with particular focus on qualification and validation as well engineering standards specific to facilities, Utilities and Equipment.
What you need to apply:
Degree in a Science, Engineering, or computer science discipline
Minimum 5 years’ experience in the pharmaceutical industry in a C&Q / Validation role.
Extensive Knowledge of Pharmaceutical Regulatory Requirements.
Experience in working with Pharmaceutical Equipment Manufacturers.
Multi-disciplinary experience: Facilities, Utilities, Equipment, Cleaning, Sterilization, Inspection, Computer System Validation and Process validation.
Must have previous experience in a project management role, managing of a team of C&Q engineers
Experience in Risk based Verification (RBV). Detailed Understanding of risk-based verification requirements for facility, utility, and equipment (FUE) qualification.
Experience with conjugation and aseptic fill finish manufacturing practices.
High degree of knowledge of all relevant EU/FDA regulations.
Strong understanding of current data integrity and data management requirements.
Demonstrated ability to coordinate activities in an efficient and effective manner.
Experience with paperless validation solutions such as Kneat would be beneficial.
Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
