Digital Quality Manager

CSL Vifor; Maidenhead; On-site; GBP 50,000 - 85,000; Full time

Job summary

CSL Vifor in Maidenhead is seeking an experienced quality systems specialist to support GMP compliance and drive continuous improvement across validation, calibration, and document management.

You will write and manage validation plans, participate in audits, and advise project teams on GxP requirements for computerized systems, with collaboration across functions.

The role requires a bachelor in engineering or a relevant science and at least 5 years in pharma quality systems.

Qualifications

• Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience
• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
• Knowledge of current Good Manufacturing Practices (cGMP)
• Knowledge of FDA and EMA requirements

Responsibilities

• Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
• Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)
• Participates in project teams to provide review and approval of project Validationdocumentation according to applicable approval matrix or procedures
• Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
• Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained
• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects
• Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics
• Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems
• Collaborates to resolve technical issues, provide quality training and communicate best practices

Skills

Quality systems

GxP compliance

Validation

Internal audits

Regulatory knowledge

SOPs

Problem solving

Education

Bachelor degree in Engineering or a relevant scientific discipline

Tools

LIMS

Job description

Responsibilities:

• Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines

• Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)

• Participates in project teams to provide review and approval of project Validationdocumentation according to applicable approval matrix or procedures

• Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management

• Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained

• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects

• Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics

• Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems

• Collaborates to resolve technical issues, provide quality training and communicate best practices

Qualifications:

• Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience

• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment

• Knowledge of current Good Manufacturing Practices (cGMP)

• Knowledge of FDA and EMA requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.