Senior Quality Assurance Associate (Pharmaceutical, On-site)

Job summary

This role focuses on ensuring quality in drug substance operations, emphasizing fast, high-quality decision-making to enhance production efficiency and compliance in a dynamic environment.

Qualifications

• Over 5 years of experience in drug substance manufacturing (API/biologics) under cGMP/GDP regulations.
• Strong understanding of GxP legislation and its practical application on the production floor.
• Proven ability to make quick, informed decisions while maintaining product quality.
• Degree in Biotechnology, Pharmacy, Medicine, Chemistry, Biology, or a related field.
• Collaborative mindset with a focus on team success.

Responsibilities

• Enhance right-first-time performance and streamline production processes.
• Approve deviations, CAPAs, and change controls to ensure product quality.
• Conduct regular production floor walks to confirm processes and provide coaching.
• Maintain clear and compliant documentation for procedures and work instructions.
• Manage and resolve deviations and CAPAs, implementing preventive measures.
• Perform risk assessments to facilitate batch movement without compromising compliance.
• Serve as the QA representative during audits and inspections, providing necessary documentation and rationale.
• Review and approve tasks related to drug substance production, ensuring team alignment.

Skills

• Strong decision-making skills with a focus on quality assurance.
• Excellent communication skills to explain decisions and processes clearly.
• Ability to work collaboratively in a fast-paced environment.

Education

• Bachelor's degree in a relevant scientific field such as Biotechnology, Pharmacy, Medicine, Chemistry, or Biology.

Tools

• Familiarity with quality assurance tools and methodologies in a pharmaceutical setting.