QA Validation Specialist
1 month ago
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope & Responsibilities:
The QA Validation ensures that all commissioning and qualification activities under the project scope is designed in compliance with all applicable site Quality policies, regulatory requirement, and GMP practices/ procedures in place and in use within the site.
- Design, construction, commissioning and qualification of new facility, equipment technology and system
- Review and approve validation master plans (VMP) and protocols for equipment, processes, and systems
- Define validation strategies, schedules, and resource requirements
- Review, and approve validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Execute validation protocols and coordinate with cross-functional teams to ensure timely completion
- Review and approve deviations or non-conformances during validation activities
- Implement corrective and preventive actions (CAPA) to address root causes
- Execute quality compliance gap assessment exercises at appropriate stage of the project lifecycle
We are looking for professionals with these required skills to achieve our goals:
- Min degree in Science or Engineering disciplines
- Min 3 years of experience in pharmaceutical industry
- Experience in automation system validation activities (Preferred)
- Understanding of cGMP and regulatory requirement within pharmaceutical industry
- Background in Computerized systems
- Background in equipment, facility validation experience
- Good knowledge of safety and environmental regulation
- Hands-on experience in pharmaceutical manufacturing (Preferred)
- Developing Project management skills or had hands-on experience in Project management (Preferred)
- Experience in start-up projects (Preferred)
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