We are currently looking for a Data Integrity Specialist to join a leading CDMO company based in the Kent area. As the Data Integrity Specialist you will be the point of reference for the Data Integrity compliance for the site. This will include understanding of ALCOA principles and the Data Integrity of all manufacturing and laboratory software driven equipment.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Data Integrity Specialist will be varied however the key duties and responsibilities are as follows:
1. Assure compliance of all systems on site with Data Integrity Guidelines.
2. Administration of laboratory systems including the Empower 3 CDS system providing a Quality System to ensure the use of the system in compliance with regulatory guidelines.
3. Review of laboratory computer based systems and standalone systems to ensure compliance with principles of Data Integrity. Input to other departments systems if required. Implement remedial action plans were required.
4. Provide training to others on site in the requirements of data integrity.
To be successful in your application to this exciting opportunity as the Data Integrity Specialist we are looking to identify the following on your profile and past history:
1. Understanding of 21 CFR Part 11, GAMP 5 and MHRA GMP Data Integrity Definitions and Guidance for Industry Mar 2018.
2. Experience of Pharmaceutical Production and associated equipment and systems.
3. Familiarity and training on analytical software packages, database systems and laboratory informatics.
Key Words: Data , Integrity , Specialist , GMP , Validation , System , Software , Quality
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.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Elliott Harvey
- Phone: 0203 910 2980
- Reference: J5634128
Website: Hyper Recruitment Solutions
- Posted: 5th January 2021
- Expires: 2nd February 2021