Description

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

This role is on-site.

Responsibilities

• Lead Corrective and Preventive Action (CAPA) activities and investigations.
• Perform quality reviews for protocols, functional specifications, detailed design specs, site acceptance tests, and data packs.
• Investigate deviations and serve as the final approver for related documentation.
• Interface with cross-functional teams to meet strict project deadlines.

Required Skills

• 6 to 9 years of experience in pharmaceutical, biopharmaceutical, or related manufacturing industries.
• Strong working knowledge of Quality System Regulations (QSR).
• 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