Job Overview
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We are seeking a highly skilled Site Validation Specialist to join our team. In this role, you will be responsible for coordinating the development and maintenance of site validation programs.
The ideal candidate will have experience in ensuring compliance with regulatory, quality, and compliance requirements.
Key Responsibilities:
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* Validate site equipment, utilities, processes, and software to ensure they meet regulatory standards.
* Develop and execute Site Validation Master Plans to drive process improvement.
* Collaborate with cross-functional teams to implement site validation programs and quality assurance activities.
* Manage validation, exception event, and change control processes to maintain overall cGMP compliance of production areas.
* Document all activities in line with cGMP requirements and update validation procedures, job instructions, and batch documentation as needed.
Requirements:
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* Bachelor's degree in a relevant field such as engineering, science, or quality assurance.
* Minimum 3 years of experience in site validation, quality assurance, or a related field.
* Strong understanding of cGMP regulations and industry best practices.
* Excellent communication and project management skills.
Benefits:
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* Competitive salary and benefits package.
* Opportunities for career growth and professional development.
* A dynamic and supportive work environment.