QA Validation Specialist
Are you an experienced QA Validation Specialist looking for a new exciting job opportunity?
We are currently looking for a QA Validation Specialist to join a leading biotechnology company based in the Central Belt of Scotland.
As the QA Validation Specialist you will support validation activities associated with equipment, process, facilities and computer software/systems to ensure compliance with applicable cGMP regulations and SOPs. You will work closely with quality, manufacturing, product development and the facilities team 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 regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for providing expertise in the area of validation including but not limited to; laboratory and process equipment validation, process validation, cleaning validation as well as computer systems validation. This includes reviewing qualification / re-qualification plans and reports for Grade A/B GMP manufacturing facilities and equipment.
2. You will review and approve qualification and validation documents IQ/OQ/PQ, both external and internal. Additionally, review and approve validation master plans, review of deviations, non-conformances associated with validation activities as well as review and provide input into the periodic review and revalidation programme.
3. As the QA Validation Specialist, you will also be responsible for ensuring that the 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.
4. Lastly, you will also investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and or improvements.
To be successful in your application to this exciting opportunity as the QA Validation Specialist we are looking to identify the following on your profile and past history:
1. Proven industry experience in a similar validation role within a cGMP regulated environment and managing a quality management system is essential for this position.
2. Proven industry experience in using Q-Pulse management system and good understanding and knowledge of GMP cleanrooms operating at Grade A/B level would be highly desirable.
3. Good understanding of GxP computer systems and data integrity compliance would also be advantageous.
Key Words: QA Validation Specialist | Quality Assurance | GMP | Pharmaceutical | Biotechnology | Life Science | Cell Therapy
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
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