Technical Quality Specialist

£0 per annum
24 Jul 2017
21 Aug 2017
William Blohm
Contract Type
Full Time
The Role
The role involves working within the Technical Quality Team to deliver qualification and validation in compliance with global policies and standards.

As part of the team you will be responsible for a range of activities including:

- Facility, equipment and utility qualification
- Process and packaging validation

Additionally the candidate will be required to be a local subject matter expert on validation and support ongoing project and initiatives.

The role will require occasional travel, including site visits to Northern Ireland.


- Actively assist in co-ordinating and be involved in the execution of all stages of the validation life cycle including:

- Assisting with development of project design documentation.
- Generating validation plans for larger projects.
- Risk assessing validation requirements.
- Liaison with non-Pharma Services personnel (including manufacturers, suppliers, external validation resources, clients)
- Preparation of validation protocols and reports
- Collation and analysis of process validation data
- Performing and witnessing validation activities

- Assist in the monitoring and periodic revaluation of equipment and processes

- Regularly update the schedule of current validation projects

- Liaise with key personnel within project teams to ensure validation tasks are planned, monitored and completed in a timely manner

- Assist in the execution of testing to meet operational requirements

- Liaise with Quality Control/Analytical to ensure that all relevant validation testing is performed and reported.

- Liaise with Quality Assurance to ensure GMP is adhered to in all areas of validation testing and that systems are fully validated and all documentation completed before they are released for use.

- Keep abreast of the regulatory environment surrounding qualification and validation.

- Act as a Subject Matter Expert (SME) as applicable, in support of planned and unplanned changes.

- Provide review and approval on a range of technical documents including Standard Operating Procedures (SOPs'), Master Batch Records (MBRs') and Technical Protocols and Reports etc.

- Participate in local and global business projects as and when required.

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