Specialist QO - Vaccine
The successful candidate will operate as a Quality Operations Validation Professional. In this role, they will provide oversight of the execution of the validation system, ensuring that contemporary compliance standards and conformance to site procedures are maintained. The ideal candidate will possess skills and experience in both equipment validation, and automation/computer validation.
- Reviews change control and performs validation impact assessments for new equipment/processes and changes to existing equipment/processes.
- Represents the unit as a customer interface on equipment/process teams to support all phases of validation.
- Reviews and approves verification and change control documentation supporting new equipment/processes and changes to existing equipment/processes.
- Supports validation as an SME during customer and regulatory audits for all areas of responsibility.
- Participates in execution of unit performance objectives.
- Supports and facilitates compliance initiatives.
- Supports the unit where needed to assure due dates and customer needs are met.
- Performs additional tasks as determined by the department manager to support the unit.
- Bachelor’s degree in a scientific discipline with a minimum of one year of experience in a pharmaceutical environment
- GMP and/or pharmaceutical validation and change control experience preferred. Excellent written and verbal communication skills, with the ability to interact with senior leadership and regulatory agencies.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Weekends and/or holidays may be required.
Other Job Details:
- Last Date to Apply for Job: August 13, 2021
- Eligible for Relocation Package