What are the responsibilities and job description for the QA Engineering Specialist position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities investigations and evaluation of change control.
- Ensure IT systems are designed, set up and function in a GMP-compliant manner to safeguard and maintain the safety and quality of Client's products.
- Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations.
- Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
- Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
- Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.
- Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
- Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
- Sponsor and support the change initiatives and the implementation of process improvement initiatives.
- Ensure site is compliant with global and regulatory data governance and data integrity requirements.
- Support any other goals and objectives of the site Quality Assurance organization, as needed.
- Must have advanced knowledge and experience with GMP, Quality and compliance.
- Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred.
- B.S. degree required.
- 8 years of experience in the pharmaceutical or related industry required.
- Equivalent combination of education and experience acceptable.
- Advanced level experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation.
- Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).
- Drives use of best practices during IT systems design, validation, and use.
- Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
- Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
- Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Consults management for advice on complex issues.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Drive strong collaboration within the site and across the network.
