QC Compliance Manager
Location: Near Sellersville, PA
The Quality IT Systems Lead oversees and directs Quality projects at the site level, serving as a liaison between site and corporate quality management (Information Systems). They resolve computer quality issues, promote communication, and improve site Quality IT/IS processes.
Job Description
• Review and approve regulatory computer system documentation.
• Ensure consistent use of policies, procedures, standards, and guidelines.
• Coordinate compliance audits and in-process audits.
• Develop and maintain site repositories for computer validation and maintenance documentation.
• Provide consultation and oversight for Quality IT and other computer system projects.
• Assist in resource assessment, scheduling, and management of outside contractors.
• Develop cost estimates and track schedules for Quality IS projects.
• Define and ensure compliance with Site-specific IT system SOPs.
• Define validation strategy and review validation deliverables for QC/Manufacturing systems.
• Provide support for site-specific projects by the Corporate IT team.
• Collaborate with Site DICO and IT SPOC for Data integrity compliance.
• Investigate incidents/deviations and define RCA and CAPA accordingly.
• Conduct trainings and awareness programs on CSV and IT Compliance.
• Attend Governance meetings and ensure adherence to corporate standards.
• Coordinate all Quality IT activities at the site.
• Implement and manage site activities according to the Quality IT strategic plan.
Qualifications:
- B.S. in Chemistry or related science.
- 3 years of laboratory experience.
- Knowledge of quality practices, metrics development, project management, automated system validation, data integrity, and electronic records.
- Familiarity with pharmaceutical automation systems is a plus.
- Understanding of validation requirements for software and equipment.
- Technical troubleshooting ability in a pharmaceutical environment.
- Strong decision-making skills, resilience, and commitment to improvement.
- Experience in training and supporting analysts.
- Proficiency in MS Office
For more information or immediate consideration send resume to lisabarrett@scientificsearch.com, job#17923
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