
Validation Specialist
1 week ago
Job Overview
This role involves supporting qualification activities, encompassing development, support, and implementation. The individual must ensure that qualification activities are carried out in accordance with company policies, procedures, and regulatory requirements.
Key Responsibilities:
- Support equipment, facilities, and utilities qualifications
- Develop validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and complete execution in a timely fashion
- Manage qualification execution and lead qualification deviation investigations encountered during qualification
- Collaborate with multiple functions to arrange, plan, and ensure smooth running of qualification activities
- Participate in site Validation Maintenance Program
- Support Change Implementation on site
- Perform other tasks as assigned by supervisor/Manager
About You:
To be successful in this role, you will need:
- A degree in Engineering or Science from a recognized institution
- At least 2 years of experience in Equipment Qualification in the pharmaceutical/biotech industry
- Experience in Critical Utilities, process equipment, and facilities qualification is preferred
- Must have experience in controlled temperature chamber qualification with temperature mapping
- Good knowledge and experience of the practical and theoretical requirements of validation programs in GMP facilities
- Good knowledge of Upstream, Downstream, and Support Services equipment within the Pharma Biotech Industry
- Excellent oral and written communication skills
- Meticulous and systematic approach
- A team player with a strong focus on safety, quality, and timeline
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