QA Validation Specialist
TC BioPharm
Holytown, Escocia
1d ago

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
  • 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
  • QUALIFICATIONS

  • 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.

    Office based.

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