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GMP Validation Specialist
The Gxp Recruitment Company
Motherwell, North Lanarkshire, North Lanarkshire
Full-Time
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GxP Recruitment invites applications on behalf of our biotechnology client in Scotland’s Central belt where an excellent opportunity has now arisen for a QA Validation Specialist to join their team on a permanent basis.
Key duties include:
* Review qualification/re qualification plans and reports for Grade A/B GMP manufacturing facility and equipment
* Computer system qualification/validation
* Ensuring expectations regarding data integrity are complied with through appropriate equipment validation.
* Laboratory and process equipment validation
* Process validation
* Cleaning validation
* Prepare and maintain policies and SOPs associated with validation
* Ensure that all change controls are assessed for impact on validation
* Review and approval of validation master plans
* Review of deviations and non-conformances associated with validation activities
* Review and provide input into the periodic review and revalidation programme
* Ensure facilities, processes, equipment and systems used for GMP are validated to the appropriate standards Review validation activities as part of any facility design, qualification or requalification to meet regulatory expectations
* Review and approve qualification and validation documentation both external and internal IQ/OQ/PQ
* Ensure appropriate interpret IQ/OQ/PQ documentation
* Ensure that equipment and processes used in the manufacture, storage and distribution of products are subject to effective validation and that documentation used in validations are approved.
* Good understanding and knowledge of GMP cleanrooms operating at grade A/B level and the validation requirements
* Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and or improvements
The ideal candidate:
* Degree in a relevant life science or similar
* Previous experience in a similar role within GMP
* Experience in successful management of quality management systems
* Experience in using Q-Pulse electronic management system would be highly desirable
* Good understanding of GXP computer systems and data integrity compliance
* Good understanding and knowledge of GMP cleanrooms operating at grade A/B level is desirable
Key duties include:
* Review qualification/re qualification plans and reports for Grade A/B GMP manufacturing facility and equipment
* Computer system qualification/validation
* Ensuring expectations regarding data integrity are complied with through appropriate equipment validation.
* Laboratory and process equipment validation
* Process validation
* Cleaning validation
* Prepare and maintain policies and SOPs associated with validation
* Ensure that all change controls are assessed for impact on validation
* Review and approval of validation master plans
* Review of deviations and non-conformances associated with validation activities
* Review and provide input into the periodic review and revalidation programme
* Ensure facilities, processes, equipment and systems used for GMP are validated to the appropriate standards Review validation activities as part of any facility design, qualification or requalification to meet regulatory expectations
* Review and approve qualification and validation documentation both external and internal IQ/OQ/PQ
* Ensure appropriate interpret IQ/OQ/PQ documentation
* Ensure that equipment and processes used in the manufacture, storage and distribution of products are subject to effective validation and that documentation used in validations are approved.
* Good understanding and knowledge of GMP cleanrooms operating at grade A/B level and the validation requirements
* Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and or improvements
The ideal candidate:
* Degree in a relevant life science or similar
* Previous experience in a similar role within GMP
* Experience in successful management of quality management systems
* Experience in using Q-Pulse electronic management system would be highly desirable
* Good understanding of GXP computer systems and data integrity compliance
* Good understanding and knowledge of GMP cleanrooms operating at grade A/B level is desirable
Recommended skills
Storage (Warehousing)
Validations
Product Quality Assurance
Good Manufacturing Practices
Quality Management Systems
Manufacturing
Job ID: 212863205
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