Description

You will manage quality assurance processes and documentation within a pharmaceutical or biopharmaceutical manufacturing environment.

Responsibilities

• Lead Corrective and Preventive Action (CAPA) activities.
• Perform quality reviews for protocols, functional specifications, detailed design specifications, site acceptance tests, and data packs.
• Investigate deviations and act as the final approver for related documentation.
• Interface with cross-functional teams to meet strict project deadlines.
• Manage multiple concurrent projects while maintaining high attention to detail.

Required Skills

• 6 to 9 years of experience in a pharmaceutical, biopharmaceutical, or related manufacturing industry.
• Strong working knowledge of Quality System Regulations.
• Proven experience managing Quality Systems.
• Experience leading CAPA processes.
• Technical background in investigating deviations and document approval.
• Bachelor's Degree in an engineering or technical discipline.
• Strong verbal and written communication skills.

Preferred Skills

• Master's Degree in a technical discipline.
• Background in life sciences.

Key Skills

Education

Bachelor's or Master's degrees