Schedule, execute and review Continuing Qualification activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
• Strong Quality background and familiar with Site change controls in general.
• Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Schedule, execute and review Continuing Qualification activities for large and small equipment.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Reviews, edits and approves change controls, SOPs, reports and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Collaborates with functional departments to resolve issues.
• Trains/advises less experienced Specialists.
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Manage and drives projects and prepares status reports.
• May present at both internal and external (regulatory) audits.
• Stays current with industry trends, regulatory requirement updates, and communicating same to team.
• May manage full time employees and/or contingent workers.
• Performs other duties assigned by Management.
• Some travel may be required.
• BS/BA in Engineering, Chemistry, or Life Sciences.
• 5+ years of related experience within the field preferred.
Purpose: The Technical Specialist will be a key team member in the Technical CoE, which provides technical expertise to a...Apply For This Job
Purpose: The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing...Apply For This Job
Purpose: Mgr/ Sr Mgr role, key member of the operations management team at Raheen. Provides technical management and support to...Apply For This Job
Purpose: Oversee daily operation and communication for samples submitted from Manufacturing, QA Validation, and QC labs. Ensure chain of custody...Apply For This Job
Purpose: Responsible for the QC Raw Materials laboratory team. Has technical responsibility for all chemical aspects of QC testing. Responsibilities:...Apply For This Job