Your new company

Your new role

• This specific role is required to perform activities such as Annual Product Quality Reviews; management, collation and processing of Regulatory Requests submitted to GSIUC QA.
• Review & Approval of Deviations/Change Controls/Procedures, support the updates and site for quality systems processes such as deviations, change controls, data integrity and QRM.
• Drives improvements to the QMS processes.
• Participate within inter-departmental, cross-functional & cross-site teams
• Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
• Management, collation and processing of Regulatory Requests submitted to GSIUC
• Authors Annual Quality Review site contributions and co-ordinates with a global team
• Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.

What you'll need to succeed

• 6+ years of relevant experience in a GMP environment related field and a BS.

• 4+ years of relevant experience and an MS.

• Prior experience in the pharmaceutical industry (ideally within a QA role)

• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)

• Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards

• Maintains and develops programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.