What are the responsibilities and job description for the QAIT Quality Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Engage with both Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron's Quality System requirements.
- Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
- Provides support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc.
- Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits.
- Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
- Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects.
- Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation process.
- Assist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity.
- The Consultant will serve as SME by supporting investigations, risk assessments, and IT Operations while verifying that GxP computerized systems operate as expected post-validation.
- The Consultant will work with multiple functional areas to support in establish policies and procedures to ensure compliance with GxP industry regulations.
- The Consultant will work with multiple functional areas to support in establish policies and procedures to ensure compliance with GxP industry regulations.
- 7 years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment.
- Thorough understanding of IT CSV and QAIT roles and responsibilities in support of GxP compliance is required.
- Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification.
- Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing).
- Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
- Understanding of root cause analysis and risk management techniques.
- Experience with quality management systems including change control, incident management, and deviation management.
- Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
- Continuously drive to improve processes for improved performance.
- Excellent technical writing and communication skills.
- Excellent analytical and problem-solving skills.
