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:Develop and maintain quality assurance procedures, policies, and systems.Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP and other relevant regulations.Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality.Provide consistency across all computer systems areas by participating in IT and process automation organizations.Regulatory Compliance:Stay updated with industry regulations, guidelines, and best practices.Assist in the preparation and execution of regulatory inspections and audits.Ensure compliance with processes such as periodic review, change control, deviation management, backup and archive, security, and other support processes for systems.Documentation and Reporting:Maintain accurate and comprehensive quality records, change control documentation, and quality reports.Develop local procedures for computer systems and ensure consistent interpretation and implementation of global policies across all computer systems areas.Quality Improvement Initiatives:Identify opportunities for process improvement and collaborate with cross-functional teams to implement changes.Participate in risk assessments and quality improvement projects.Training and Development:Provide training to staff on all relevant aspects of computer system quality.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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