Job Title: Contractor - Quality Systems Specialist (Validation & Compliance)
Location: Remote - India
How will you make an impact?
The Quality Systems Specialist (Validation & Compliance) will provide Quality Assurance support for the TrackWise Digital (TWD) platform and Global Digital Quality & Compliance organization. This role will be responsible for independent review and approval of computerized system validation deliverables, support quality system processes, and contribute to compliance activities that ensure adherence to regulatory requirements and company procedures. The contractor will partner with global project teams, business stakeholders, and IT resources to support successful implementation, validation, and transition to operational support.
A Day in the Life / What Will You Do?
Quality Assurance Oversight
- Perform independent QA review and approval of validation deliverables.
- Ensure validation documentation complies with internal procedures, data integrity requirements, and applicable regulatory expectations.
- Review and approve validation plans, requirements, risk assessments, test protocols, test evidence, traceability matrices, summary reports, change controls, deviations and other related documentation.
- Verify validation activities are executed according to approved plans and procedures.
- Identify compliance risks, documentation gaps, and quality concerns and work with project teams to resolve findings.
- Provide QA guidance throughout the system development and validation lifecycle.
- Participate in project meetings and design reviews.
- Support regulatory inspection readiness by ensuring validation documentation is complete and audit-ready.
- Assist with process improvements and application of Computer Software Assurance (CSA) principles where appropriate.
Quality Systems & Compliance
- Support and coordinate quality activities for deviations, investigations, CAPAs, change controls, and effectiveness verification.
- Perform quality review of records to ensure compliance with company procedures and regulatory requirements.
- Support inspection readiness and continuous improvement initiatives.
- Participate in quality metrics and compliance monitoring activities.
- Support supplier qualification activities, supplier assessments, supplier quality documentation, and ongoing supplier performance monitoring.
- Support execution of periodic reviews for validated computerized systems and related quality processes, including review of system performance, compliance status, change history, deviations, CAPAs, and training effectiveness.
How Will You Get Here?
Education
- Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Systems, Quality Management, or related discipline.
Experience
- Minimum 5 years of experience in Quality Assurance, Computer System Validation, or Quality Compliance within a regulated environment.
- Experience supporting pharmaceutical, biotechnology, medical device, or other GxP-regulated industries.
- Experience reviewing and approving validation documentation for GAMP Category 3, 4, and 5 systems.
- Experience with quality systems including Change Control, Deviations, CAPA, and Risk Management.
- Experience with supplier qualification, periodic review, deviation management, and CAPA processes is preferred.
- Experience supporting enterprise software implementations is preferred.
Knowledge, Skills, and Abilities
- Experience with MasterControl, TWD, ServiceNow, or similar quality/compliance systems is a plus.
- Strong knowledge of GAMP 5, Computer Software Assurance (CSA), Data Integrity, Annex 11, and 21 CFR Part 11.
- Understanding of GxP regulations and validation lifecycle requirements.
- Excellent technical document review and approval skills.
- Strong analytical and problem-solving capabilities.
- Ability to work effectively across global teams and multiple time zones.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced project environment.
