GMP Quality Systems Lead (Validation & Compliance)

CSL; Maidenhead; On-site; GBP 50,000 - 70,000; Full time

Job summary

CSL Seqirus is seeking a seasoned Quality Systems Specialist to support GMP-compliant quality programs and validation activities. The role focuses on maintaining SOPs, leading audits, and guiding project teams on GxP requirements for computerized systems.

You will contribute to CAPA, Change Control, and Validation efforts, ensuring timely validation and continuous improvement across the quality function in a fast-paced pharmaceutical setting.

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 SOPs.
• Participates in project teams to review and approve Validation documentation according to applicable 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 audits; plans and implements continuous improvement projects.
• Supports GxP health authority inspections by serving as subject matter expert for computerized systems topics.
• Provides guidance on quality and regulatory requirements to project teams and internal stakeholders on GxP compliance relating to computerized systems.
• Collaborates to resolve technical issues, provide quality training and communicate best practices.

Skills

Quality systems

GMP

Validation

Audits

CAPA

LIMS

Computerized systems

Regulatory knowledge

Education

Bachelor degree in Engineering or Life Sciences

Tools

LIMS

Document Management System

Job description

CSL Seqirus is seeking a seasoned Quality Systems Specialist to support GMP-compliant quality programs and validation activities. The role focuses on maintaining SOPs, leading audits, and guiding project teams on GxP requirements for computerized systems.

You will contribute to CAPA, Change Control, and Validation efforts, ensuring timely validation and continuous improvement across the quality function in a fast-paced pharmaceutical setting.