System Validation

5 days ago

Islamabad, Islamabad, Pakistan OIRRC Full time 900,000 - 1,200,000 per year

Job Title:

System Validation & Quality Assurance Specialist

Employment Type:

Full-Time

Position Overview:

We are seeking a detail-oriented and proactive System Validation & Quality Assurance Specialist to play a dual role in system validation testing and quality assurance management. This role is split evenly between ensuring system implementations and updates meet regulatory and operational standards and supporting the development and enforcement of quality assurance measures across clinical operations, regulatory compliance, and vendor oversight.

Key Responsibilities:

System Validation (50%):


• Develop and execute comprehensive system validation testing plans in line with regulatory requirements.


• Conduct risk assessments to identify potential compliance issues in system updates and new implementations.


• Collaborate with IT and security teams to verify system functionality, data integrity, and security protocols.


• Maintain detailed documentation of validation testing results and compliance findings.


• Draft and manage policies, procedures, and forms to support system validation testing.


• Ensure adherence to industry standards, including ISO, NIST, FDA validation, and other applicable frameworks.


• Provide recommendations to enhance system reliability and regulatory adherence.


• Assist in audits by preparing relevant compliance reports and documentation.

Quality Assurance (50%):


• Develop and maintain SOPs, audit policies, and other quality management documents to align with regulatory standards.


• Conduct and oversee internal and external audits, ensuring adherence to regulatory guidelines.


• Manage quality assurance for third-party vendors and subcontractors, ensuring they comply with organizational and regulatory standards.


• Analyze audit findings, generate detailed reports, and track KPIs to support continuous improvement efforts.


• Identify and address recurring quality assurance issues through corrective and preventive actions (CAPAs).


• Support staff training on data quality principles, auditing procedures, and database management.


• Facilitate communication and collaboration with clinical operations, research and development, and regulatory affairs to ensure quality standards are met across all functions.


• Assist in the development and management of forms to streamline interdepartmental workflows.

Qualifications & Skills:


• Bachelor's degree in Information Technology, Computer Science, Quality Assurance, or a related field.


• Strong experience in system validation, compliance audits, and/or quality assurance practices.


• Proficiency in regulatory standards (ISO, NIST, FDA validation) and risk assessment methodologies.


• Excellent analytical skills and attention to detail in both compliance testing and quality management.


• Strong communication and documentation skills, with the ability to work cross functionally.

Preferred Experience:


• Experience in regulated industries (e.g., healthcare, finance).


• Relevant certifications such as CCP, CISA, or equivalent.


• Familiarity with automated testing tools and compliance tracking software.


• Experience in mentoring or leading junior staff members.

Work Hours:


• Full-time, Monday through Friday, with occasional weekend availability based on project timelines and deadlines.


• Work hours will include at least 5-6 hours of overlap with the U.S.-based leadership team, particularly during the initial phase.

Work Venue:


• Islamabad or Peshawar, with the possibility of a hybrid work arrangement based on performance and operational needs.

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