Metrology Technician III - Harrogate, United Kingdom
The Equipment Management Associates will perform all activities with regards the GxP compliance of all CMC equipment.
The individual has a responsibility to work with BioPharmCMC sections and BioPharmCMC management etc where appropriate to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GLP and or GCP / and or GMP) specified in the study plans, protocols, or work agreements governing the work in which they are involved.
Reports to Choose from list on a daily basis (a permanent change of supervisor will be documented in training records) and to the relevant QC SCi on a study specific basis.
The post holder will ensure adherence to the BioPharmCMC SOPs and will be responsible for completion of all relevant documentation.
- Adhere to and/or complete all equipment documentation. This includes, but is not limited to:
- Standard Operating Procedures (SOP)
- Equipment Training Documentation
- Metrology Specification Requests (MSR)
- Equipment Qualification Documents (e.g., IQOQs, job tasks)
- Other equipment validation documents (e.g., risk assessments, URS, etc.)
- Supplier Approval Request Forms (SARF)
- Asset management system (TMS) Forms
- Work Orders
2. Coordinate with in house or vendor maintenance and qualification activities:
- Work with Operations to determine appropriate timeframe for maintenance
- Schedule maintenance with Facilities Management (FM)
- Escort vendors during maintenance and qualification activities
- Ensure vendors meet GMP compliance requirements (i.e., approved supplier, training documents obtained, etc.)
- Manage “Do Not Use” tags to ensure instrumentation downtime is minimized
3. Where required arrange for the installation and set-up of new equipment.
4. Complete GMP quality records to an appropriate standard related to equipment failures and changes:
- Change Controls
- Audit Comments
5. Compose documents from concept
- Write IQ/OQ/PQ documents for internal execution
- Compose SOPs and Policies as QDMS author
6. Serve as the subject matter expert (SME) and main point of contact for equipment / process
7. Arrange purchases for GMP EM Team or Operations
- Gather quotes / contracts from appropriate service providers
- Execute PO Requisitions / ePro submissions
8. Approve documentation completed by other associates with instrument knowledge confidence
9. Engage in improvement initiatives towards a singular process for all EM processes and documents.
- Work on process harmonization across GMP sties (SOPs / IQOQPQ documents)
- Coordinate / collaborate on continuous process improvements across GMP sites
10. Assist Global Business Technologies (GBT) and other areas of Global Laboratory Systems to assist in computer system validation (CSV) activities:
- Determining the scope of the validation testing
- Test script execution
11. Serve as SME for complex analytical instrumentation (e.g. HPLC, UPLC, Mass Spec)
12. Coordinate large project scopes to ensure proper execution and timely completion
13. Prioritize GMP EM Team function
- Prioritize daily responsibilities of associates according to business needs
- Determine associates area of GMP EM responsibility and determine cross training opportunities
- The post holder should ideally have a relevant scientific degree and/or an appropriate amount of experience.
The post holder should typically have:
- Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
- An understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs.
- The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.
This job was originally posted as www.emedcareers.com/job/960521422