Senior Validation Specialist
hace 6 días
We are seeking a highly skilled Senior Validation Specialist to join our team at Mirus Consulting Group in Humacao, Puerto Rico.
About the RoleThis is an exciting opportunity for a senior quality assurance professional to lead our validation efforts and drive process improvements across our organization. As a key member of our team, you will be responsible for ensuring that all aspects of our operations meet the highest standards of quality and compliance.
The ideal candidate will have a strong background in quality assurance, validation, and project management, with experience working in a fast-paced environment. You will be expected to collaborate closely with cross-functional teams, provide guidance and support to junior staff members, and stay up-to-date with industry developments and best practices.
Responsibilities- Review and approve product masters
- Approve process validation protocols and reports for manufacturing processes
- Represent Quality on incident triage team
- Approve Environmental Characterization reports
- Release of sanitary utility systems
- Approve planned incidents
- Represent QA on NPI team
- Lead investigations
- Lead site audits
- Own site quality program procedures
- Designee for QA manager on local CCRB
- Review Risk Assessments
- Support Automation activities
- Support facilities and environmental programs
- Review and approve Work Orders
- Review and approve EMS/BMS alarms
- Approve NC investigations and CAPA records
- Approve change controls
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience
- Fluent in English and Spanish, including writing
- Strong English technical writing skills
- Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
- Problem solving skills
- Experience working with dynamic cross-functional teams and abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Strong leadership capabilities and experience applying GMP requirements in an operational setting
- Ability to independently interact with various levels, drives tasks to completion, and is a self-starter
$120,000 - $180,000 per annum, depending on qualifications and experience.
We offer a competitive salary package, commensurate with your qualifications and experience. In addition to your base salary, you will receive a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Mirus Consulting Group is an equal employment opportunity employer and welcomes applications from qualified candidates of all backgrounds.
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