Executive / senior industry position
The Senior Quality Specialist, Validation participates in the development, implementation and adherence to validation of product processes, test procedures (equipment, utilities, and cleaning), and information systems to ensure validation activities meet appropriate regulatory agency requirements, internal company standards and current industry practices.
- Responsible for validation projects through the development of validation schedules, master plans, validation protocols and reports for process, equipment, cleanrooms, utility systems, facilities to support clinical and commercial manufacturing.
- Coordinates validation activities with, and seeks team supportsfrom Manufacturing, Facilities, Quality Control, third Parties, and other groups on validation projects
- Writes/Reviews/Approves/Executes validation protocols and reports supporting the validation of equipment, systems and processes
- Provides general support to meet department goals and objectives
- Provides validation Risk Assessment, performs NC investigations, and supports Change Controland/or CAPA activities
- Mentors new team members and assists in the training of validation execution
- Supports regulatory inspections or audits
- Serves as information resource for validation technicians, contractors and vendors
- Represents department in cross-functional teams, projects and GXP related issues
- Reports/presents status and progress of validation activities or projects to the Leadership team
- Performs other Quality Assurance duties as assigned
- Ability to think critically with demonstrated troubleshooting and problem-solving skills;
- Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment
- Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities and business needs.
- 8 years of relevant validation experience in a pharmaceutical/cGMP environment.
- Ability to perform validation activities for equipment and computer-related validation (test) protocols
- Working knowledge of FDA cGXP/ICH US regulations related to validation activity is required
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