Quality Assurance Sr. Engineer (Drug Product)

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Written by AI from the job title and company, not by FUJIFILM Diosynth Biotechnologies, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Quality Assurance Senior Engineer (Drug Product) at FUJIFILM Diosynth Biotechnologies plays a pivotal role in maintaining the integrity and quality of drug products throughout the manufacturing process. This position requires a thorough understanding of Good Manufacturing Practices (GMP) and Quality Assurance principles to ensure compliance with regulatory requirements and industry standards. The candidate will be responsible for leading quality initiatives, conducting audits, and collaborating with cross-functional teams to drive continuous improvement in product quality and safety.

Job Responsibilities

• Conduct comprehensive Quality Assurance reviews of manufacturing and operational processes to ensure compliance with applicable regulations and industry standards.
• Develop and implement Quality Systems, policies, and procedures to enhance product quality and operational effectiveness.
• Lead the investigation of quality incidents and deviations, providing timely resolutions and implementing corrective actions.
• Coordinate and participate in internal and external audits, preparing relevant documentation and responses to findings.
• Evaluate and approve the manufacturing processes, procedures, and specifications for compliance with regulatory requirements.
• Provide training and support to staff regarding quality control measures and quality assurance practices.
• Regularly analyze quality data and metrics to identify trends and areas for improvement within manufacturing processes.

Qualifications

• Bachelor's Degree in Science, Engineering, or a related field; advanced degree is preferred.
• A minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), quality systems, and regulatory compliance.
• Strong analytical skills with the ability to interpret complex data and reports.
• Excellent communication and interpersonal skills, capable of collaborating with various teams and stakeholders.
• Detail-oriented with strong organizational skills.

Technologies & Tools

The Quality Assurance Senior Engineer will utilize a variety of technologies and tools such as electronic Document Management Systems (EDMS), Quality Management Systems (QMS), and statistical analysis software to manage and monitor quality-related processes. Familiarity with Laboratory Information Management Systems (LIMS) and regulatory compliance software is also essential for effective documentation and reporting.

Ideal Candidates

Ideal candidates for the Quality Assurance Senior Engineer position will possess a strong quality mindset, demonstrating a rigorous approach to problem-solving while consistently driving efforts to improve product quality and safety. They should be proactive in their roles, showcasing a strong ability to work collaboratively in a team-oriented environment. Effective communication skills and a customer-focused attitude are critical for maintaining positive relationships with both internal teams and external partners. Additionally, an adaptable mindset towards regulatory changes and continuous learning will significantly enhance their expertise in this dynamic field.