What are the responsibilities and job description for the Quality Specialist position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Provide quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements.
- Collaborate with engineering, operations, and IT teams to ensure the implementation of quality standards in automated and computer-controlled systems.
- Ensure all quality activities are conducted following applicable policies, procedures, and regulatory expectations.
- Support regulatory inspections and audits, providing documentation and responses as required.
- Lead and provide oversight for commissioning, qualification, and validation of warehouse equipment and systems.
- Review and approve validation documentation, including URS, FRS, IQ, OQ, and PQ protocols.
- Ensure appropriate risk-based approaches are applied to validation and verification activities.
- Monitor and assess changes to computerized systems and automated processes to ensure continued compliance.
- Identify opportunities for quality improvements and implement corrective and preventive actions (CAPAs).
- Support the development and implementation of quality systems, including change control, deviations, and investigations.
- Provide input into process optimization initiatives to enhance operational efficiency while maintaining compliance.
- ct as a quality advocate, providing guidance to project teams, suppliers, and stakeholders on quality and compliance matters.
- Participate in cross-functional project meetings to ensure quality considerations are integrated into project deliverables.
- Provide training and mentorship to team members on quality expectations and regulatory requirements.
Requirements :
