Job Description

Job Description

Job Description

Responsibilities:

• Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations.

• Develop, review, and approve validation documents, including validation plans, test scripts, and final reports.

• Coordinate and conduct validation activities in accordance with project timelines and business objectives.

• Implement and manage document control processes and systems.

• Evaluate and recommend improvements to existing systems and processes to enhance efficiency and compliance.

• Provide technical support and training to other team members on computer system validation and related topics.

• Participate in internal and external audits, ensuring all computer systems are compliant.

• Oversee ERP implementation, ensuring seamless integration with existing systems.

• Stay updated with the latest industry trends, regulations, and validation standards.

Requirements:

• Bachelor's degree in computer science, Engineering, or a related field.

• A minimum of 5 years of experience in Computer System Validation (CSV) in the engineering industry.

• Proficient knowledge of Document Control, 21 CFR Part 11, FDA regulations, cGMP regulations, and CSV.

• Proven experience in ERP implementation.

• Strong understanding of computer systems, including hardware, software, networking, and security.

• Excellent problem-solving skills and the ability to handle multiple projects simultaneously.

• Strong written and verbal communication skills.

• Ability to work in a team and independently as needed.

• High attention to detail and accuracy.

• Proactive, self-motivated, and able to work under minimal supervision.

• Certification in Computer System Validation or a related field would be an added advantage.

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