OVERALL ROLE OBJECTIVE
The post holder will provide Quality Assurance support for validation activities associated with equipment, processes, facilities and computer software / systems to ensure compliance with applicable current good manufacturing practice (GMP) regulations, internal policies and standard operations procedures.
They will work closely with the quality, manufacturing, product development and facilities teams to design and develop validation protocols to ensure the purpose, testing and intended outcomes are defined in compliance with the validation master plan and applicable GMP and regulatory requirements.
The QA validation specialist will join TC BioPharm Ltd (TCB), an established cancer immunotherapy company developing cell-based treatments for cancer and severe viral infections.
Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Head of Quality.
TCB is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO :
Provide expertise in the area of validation ensuring compliance to current regulations
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
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
Degree in a relevant life science or equivalent qualification
SKILLS & EXPERIENCE
At least 3 years’ 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
A good scientific knowledge of biological systems would be desirable
Excellent written / oral communication and interpersonal skills
Excellent Microsoft Office skills
Thorough approach and high attention to detail
Strong time management and organisational skills
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move.
This is an opportunity to be part of a growing, ambitious business where people development is critical to future success.
As we continue to expand, there will be career opportunities on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
Full-time, permanent role, working 37.5 hours per week Monday to Friday. Some ad hoc irregular working hours may be required.