Your new company

Your new role

• Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
• Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
• Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
• Performs QA review and release of primary and secondary packaging components.
• Performs QA review and approval of artwork.
• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
• QA Review and approval of GMP Deviation investigations and CAPAs

What you'll need to succeed

• Prior experience in the pharmaceutical industry is preferred (ideally within a QA role).
• 4+ years of relevant experience in a GMP environment related field and a BS
• 3+ years of relevant experience and an MS
• Demonstrates working knowledge of current Good Manufacturing Practices (cGMPs).
• Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
• Demonstrates working knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.

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.