Quality Systems Associate - Qualification and Administration

TN United Kingdom; England; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a Quality Systems Associate for a 12-month FTC position in Hertfordshire. This role is pivotal in ensuring compliance with SOPs within the Quality Control Laboratory and Quality Systems, focusing on electronic systems, CSV, and GAMP requirements. The ideal candidate will support electronic systems, assist with updates, and provide training on validation requirements. If you're passionate about quality systems and eager to contribute to a global pharmaceutical company, this opportunity is perfect for you.

Qualifications

• Experience with electronic systems, CSV, and GAMP standards.
• Ability to maintain and improve quality systems.

Responsibilities

• Support electronic QMS and QC lab systems as administrator.
• Implement new software applications and system upgrades.
• Prepare and update SOPs and training materials.

Skills

Effective communication skills

User requirement analysis

Knowledge of electronic systems

Understanding of data integrity principles

Familiarity with Quality Control Systems

Job description

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Quality Systems Associate - Qualification and Administration, Hertfordshire

Client: Cpl

Location: Hertfordshire, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: c19530aa8aa5

Job Views: 3

Posted: 26.04.2025

Expiry Date: 10.06.2025

Job Description:

The Quality Systems Associate role is a 12-month FTC position based in Hatfield, supporting a global pharmaceutical company. The role involves ensuring electronic systems within the Quality Control Laboratory and Quality Systems comply with SOPs, with a focus on electronic systems, CSV, and GAMP requirements.

Key Responsibilities:

1. Support electronic QMS and QC laboratory electronic systems as administrator.
2. Maintain and improve electronic systems to support company needs.
3. Assist with system updates and upgrades, ensuring systems remain qualified.
4. Implement new software applications and system upgrades.
5. Support QC Analysts in managing software and file changes in line with data integrity policies.
6. Prepare and update SOPs and training materials related to system administration.
7. Maintain TrackWise systems and processes to meet company requirements.
8. Review and write SOPs related to the electronic QMS.
9. Provide training on CSV, IT qualification, and validation requirements.
10. Participate in change control processes ensuring qualification and validation compliance.

Skills:

• Effective communication and relationship-building skills within the company and with external partners.
• Ability to analyze user requirements and facilitate system improvements.
• Knowledge of electronic systems, CSV, and GAMP standards.
• Understanding of data integrity principles and their application in system management.
• Familiarity with Quality Control Systems, analytical software, and electronic Quality Systems.

Please apply within for more information or send your CV to [contact details].