Quality Assurance Validation Specialist
We are seeking a Quality Assurance Validation Specialist to join our team on a contract basis during an exciting phase of growth.
Key Responsibilities:
* Review and approve documents related to system qualifications (e.g., IQ, OQ, PQ) for utilities.
* Oversee validation activities for utility and facility systems to ensure compliance.
* Contribute to the development and upkeep of the Site Validation Master Plan (SVMP).
* Collaborate with engineering and maintenance teams to validate new and existing utility systems.
* Investigate and address issues related to utility qualifications and implement corrective actions.
* Review calibration and maintenance records for utility equipment.
* Participate in risk assessments and technical evaluations affecting utility systems.
* Support audits as a subject matter expert (SME) for utility validation.
Requirements:
* Background in science or engineering.
* Experience working in a regulated pharmaceutical or biopharmaceutical environment.
* Knowledge of utility system validation.
* Familiarity with validation principles and regulatory standards.
* Strong documentation and communication skills.
* Ability to work both independently and within a team.