At a Glance
- Tasks: Ensure quality systems meet compliance and improve GMP-related processes.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits and a culture of inclusion and belonging.
- Other info: Dynamic work environment with opportunities for continuous improvement.
- Why this job: Make a real impact in public health while advancing your career.
- Qualifications: Bachelor's degree in a relevant field and 5+ years in quality systems.
The predicted salary is between 40500 - 49500 £ per year.
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 Validation documentation 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 for computerized 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.
Digital Quality Manager in Maidenhead employer: Seqirus UK Limited
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises inclusion and belonging, fostering a culture of curiosity and empathy. Employees benefit from comprehensive support for their well-being, alongside opportunities for professional growth within the highly regulated pharmaceutical industry. Located in the EMEA region, this role not only contributes to global health through innovative vaccine solutions but also allows for meaningful engagement with diverse stakeholders, making it a rewarding place to advance your career.
