Senior Associate - Quality for Computer Systems Validation
Company Overview: We are a global healthcare organization committed to enhancing life through the discovery and delivery of transformative medicines. Our mission is to improve health outcomes worldwide by advancing biopharmaceutical innovation.
About Us: We are a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility employs the latest bioprocessing technologies to create life-saving therapies.
Position Summary: As a Senior Associate in Computer Systems Quality, you will play a crucial role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our advanced manufacturing facility. You will collaborate closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and drive continuous improvement initiatives.
Key Responsibilities:
Quality Assurance Oversight:
o Develop and maintain quality assurance procedures, policies, and systems.
o Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP and other relevant regulations.
o Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
o Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.
o Provide consistency across all computer systems areas by participating in IT and process automation organizations.
2. Regulatory Compliance:
o Stay updated with industry regulations, guidelines, and best practices.
o Assist in the preparation and execution of regulatory inspections and audits.
o Ensure compliance with processes such as periodic review, change control, deviation management, backup and archive, security, and other support processes for systems.
3. Documentation and Reporting:
o Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
o Develop local procedures for computer systems and ensure consistent interpretation and implementation of global policies across all computer systems areas.
4. Quality Improvement Initiatives:
o Identify opportunities for process improvement and collaborate with cross-functional teams to implement changes.
o Participate in risk assessments and quality improvement projects.
5. Training and Development:
o Provide training to staff on all relevant aspects of computer system quality.
o Stay informed about advancements in computer systems validation and quality assurance.
Qualifications:
• Bachelor’s (BSc, Hons BSc), Master’s (MSc), or PhD in Science, Engineering, Quality, or a related discipline.
• 3+ years of experience in quality assurance within biotechnology, pharmaceutical, or medical device manufacturing environments.
• Strong knowledge of cGMP, FDA regulations, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
• Excellent problem-solving and analytical skills.
• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Effective communication and teamwork skills.
• Demonstrated initiative, able to work proactively without direct supervision, with a continuous improvement mindset.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is advantageous.
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