No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
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
Qualifications:
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)
