
Validation Specialist
1 week ago
We are seeking a skilled professional to fill the role of Validation Specialist. In this position, you will be responsible for ensuring the quality and compliance of our systems and processes.
Key Responsibilities:
- Implement computer system validation (CSV) in a regulated environment with a focus on Good Manufacturing Practices (GxP).
- Develop and maintain thorough knowledge of cGMP concepts, FDA/EMA regulations, QSR, and ISO 9001 standards.
- Conduct process validation, computer and equipment validation, and ensure adherence to GMPs.
- Utilize EDMS & Test Management tools to streamline workflow and enhance productivity.
- Produce clear, concise, and timely reports to stakeholders.
- Collaborate with cross-functional teams to achieve project goals and objectives.
- Manage multiple priorities and deadlines while maintaining a high level of flexibility and adaptability.
Requirements:
- 5-10 years of experience in CSV/Quality Compliance in a regulated industry (Medical Device/Pharma/Life Sciences).
- Strong understanding of fundamental cGMP concepts and FDA/EMA regulations.
- Ability to work independently and as part of a team to achieve project objectives.
Why Join Us?
As a valued member of our team, you will have the opportunity to contribute to the success of our organization and advance your career in a dynamic and supportive environment.
What We Offer:
- A challenging and rewarding work environment.
- Opportunities for professional growth and development.
- A competitive compensation package.
- A collaborative and inclusive team culture.
How to Apply:
If you are a motivated and detail-oriented professional looking to take your career to the next level, please submit your application today.
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