Quality Validation (CSV) Specialist

CK Group; England; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Quality Validation Specialist to ensure compliance of electronic systems within their Quality Control Laboratory. This role involves managing the Electronic Quality Management System and supporting the administration of QC laboratory systems. The ideal candidate will have a strong background in the pharmaceutical industry, with expertise in CSV and GMP guidelines. Join a dynamic team where your contributions will directly impact the quality of drug products and enhance system functionality. If you have a passion for quality assurance and a keen eye for detail, this opportunity is perfect for you.

Qualifications

• Significant experience in pharmaceutical industry focused on Electronic Quality Systems.
• Proficient knowledge of CSV and GAMP requirements.

Responsibilities

• Ensure compliance of electronic systems with GMP and company expectations.
• Support the management of QC laboratory system applications.

Skills

Electronic Quality Systems

CSV

GMP Guidelines

Data Integrity

Analytical Software

Communication Skills

Education

Degree in Scientific Field

Tools

Electronic Quality Management System (QMS)

Job description

CK Group Hertfordshire, England, United Kingdom

Quality Validation (CSV) Specialist

CK Group Hertfordshire, England, United Kingdom

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Principal Recruitment Consultant - Scientific, GMP and Regulatory contracts specialist

CK Group are recruiting for a Quality Validation (CSV) Specialist, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

This role is responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures

Key duties will include :

• Ensure the Electronic Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and company expectations.
• Provide input to the review and writing of any associated quality policies, systems and procedures as required and prepare and update SOPs and training materials for system administration activities, Qualification and Validation activities.
• Support the maintenance and administration of the Electronic QMS.
• Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities
• Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.
• Ensure the maintenance of procedures supporting Qualification and Validation and review and approve Qualification and Validation documentation.
• Ensure user access to systems is maintained in line with procedures and support is provided to facilitate the set up and change management of system data and ensure continuous system availability and functionality.
• Support the Management of the relationships with external system providers for technical and helpdesk support and coordinate and lead system updates and upgrades with the system providers.
• Manage the provision of training on the requirements for CSV and IT qualification and validation
• Support the change control process to ensure the requirements of qualification and validation are included.

Your Background:

• Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems
• Proficient knowledge of electronic systems, CSV and GAMP requirements and the ability to understand and analyse user requirements to facilitate changes and system improvements
• Good understanding of the requirements of data integrity and application to system management
• Good understanding of Quality Control Systems and analytical software and electronic Quality Systems
• Good understanding of GMP Guidelines and Regulations
• Knowledge of the qualification and validation requirements for equipment and electronic systems
• Excellent verbal and written communication skills.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 128 633 in all correspondence.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Manufacturing, and Science

• Industries

  Pharmaceutical Manufacturing

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