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 (current Good Manufacturing Practices) 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.
Participate in IT and process automation organizations to provide consistency across all computer systems areas.
Regulatory Compliance:
Stay current with industry regulations, guidelines, and best practices.
Assist in the preparation and execution of regulatory inspections and audits.
Ensure compliance with periodic review, change control, deviation, back up 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 common local procedures for Computer systems and help th site consistently interpret and implement global policies across all computer systems areas.
Quality Improvement Initiatives:
Identify areas for process improvement and work collaboratively with cross-functional process 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 the latest developments in computer systems validation and quality assurance.
Qualifications
BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
Minimum of 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
Strong knowledge of cGMP, FDA, 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 and with a continuous improvement mind-set.
Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus.
