We are seeking a detail-oriented and highly motivated Quality Assurance Specialist to join our quality assurance team.
Job Summary
This role plays a critical part in maintaining the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Main Responsibilities:
1. Quality Assurance Oversight:
* Develop and maintain quality assurance procedures, policies, and systems.
* Conduct routine self-inspections and monitoring assessments 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 to maintain quality.
* Participate in IT and process automation organizations to provide consistency across all computer systems areas.
2. 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.
3. Documentation and Reporting:
* Maintain accurate and comprehensive quality records, change control documentation, and quality reports.
* Develop common local procedures for Computer systems and help the site consistently interpret and implement global policies across all computer systems areas.
4. 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.
5. 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.