Validation Engineer
2 weeks ago
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 and Responsibilities:
- Responsible for executing and closing out the validation activities within the assigned area
- Develop or support the development of required validation documents, including Risk Assessments, plans, protocols, and reports
- Apply science and risk-based approach into all assigned tasks
- Support the review, analyse, interpret and summarise data of executed studies
- Investigate or support the investigating of deviations or non-conformities raised during validation studies
- Ensure safety, quality and delivery of the validation projects
- Effectively collaborate with all identified stake holders. Wherever required, collaborate with Global/Corporate functions
Qualifications:
- Minimum Bachelor's degree in science or engineering discipline
- Minimum 2 years of experience in pharmaceutical CQV
- Knowledge in the assigned area and of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices
- Fluency in written and spoken English
- Ability to work in a fast paced / dynamic work environment
- A fast learner with "Can-do" attitude
- Good time management skill and great attention to detail
- Proficient presentation and facilitation skill is a plus
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