Parexel has announced an opportunity for a Technology Quality Specialist I in India. The position is listed for Bengaluru with remote working and focuses on technology quality, GxP compliance, Computerized System Validation (CSV/CSA), clinical trial technology and quality systems.
This Parexel Technology Quality Specialist job may be particularly relevant for professionals with educational backgrounds in Pharmacy, Biological Sciences, Technology, Life Sciences or other health-related disciplines who have experience or exposure to clinical trials, GCP and technology compliance.
The Technology Quality Specialist I will support validation and assurance activities for computerized systems used in regulated clinical research environments. The position also involves quality issue management, change control, risk assessment, audit support and continuous improvement activities.
By Pharmabharat Editorial Team
Key Responsibilities
As a Technology Quality Specialist I at Parexel, selected candidates will support technology quality and compliance activities across clinical development programs.
Key responsibilities include:
- Act as a quality representative and support the implementation and maintenance of the Parexel Quality System.
- Collaborate with functional and business teams to implement quality frameworks for validation and release of technology solutions.
- Support the development and continuous improvement of SOPs, policies and other quality system documentation.
- Assist project teams with clinical trial technology validation and compliance activities throughout the applicable system lifecycle.
- Support Computerized System Validation and Computer Software Assurance activities in regulated GxP environments.
- Assist with validation planning, risk assessments, impact assessments, resource estimates and validation summary reporting.
- Support compliance with Electronic Records and Electronic Signature requirements where applicable.
- Identify technology and validation risks and assist in developing appropriate risk mitigation plans.
- Support reviews of third-party supplier validation packages.
- Assist with Quality Issue management, including issue description, classification, root cause analysis and CAPA activities.
- Support Change Control Board activities and review technology change requests from quality and validation perspectives.
- Assist audit and inspection teams with planning, coordination and technology-related documentation.
- Support preparation and finalization of responses to audit observations.
- Provide support for GxP quality and regulatory assessments of technologies used in clinical trials.
- Contribute to risk management processes based on applicable industry standards and best practices.
- Support Requests for Information and proposal activities from a quality and compliance perspective.
Qualification – Who Can Apply?
Parexel states that candidates should be educated to degree level, preferably in technology, biological science, pharmacy or another health-related discipline, or possess an equivalent qualification.
Relevant qualifications may therefore include:
B.Pharm / M.Pharm / Pharm.D / B.Sc or M.Sc in Biological Sciences, Life Sciences or related disciplines / B.Tech, B.E. or other relevant Technology degrees / other Health Science-related degrees or equivalent qualifications.
Applicants should note that the final determination of whether a particular degree is considered equivalent rests with Parexel’s recruitment team.
Experience Required
Candidates should generally have:
- Around 2–3 years of relevant experience.
- Clinical trial and/or clinical research work experience.
- Exposure to GCP and technology compliance.
- Familiarity with technology used in clinical trial activities.
- Understanding of System Life Cycle processes.
- Knowledge of GCP requirements applicable to computerized systems.
- Entry-level knowledge of project management, auditing, risk management or Lean Six Sigma methodologies.
Skills Required
Candidates interested in the Parexel Technology Quality Specialist I vacancy should have knowledge or exposure to:
- Computerized System Validation (CSV)
- Computer Software Assurance (CSA)
- GxP technology compliance
- Clinical drug development
- Phase I, II, III and IV clinical studies
- GCP regulations
- FDA regulations
- EU regulatory requirements
- ICH guidelines
- GAMP 5
- Computerized system lifecycle processes
- Electronic Records / Electronic Signatures
- Quality management systems
- CAPA
- Root Cause Analysis
- Change Control
- Risk Assessment
- Audit and inspection support
- Project management fundamentals
- Microsoft Word, Excel and PowerPoint
- Adobe Acrobat PDF
Knowledge of GAMP 5 principles, including their application to computerized system validation and assurance and emerging AI-enabled applications, will be relevant to this position.
Why This Role Is Important
Technology systems play an increasingly important role throughout modern clinical trials. Systems used for clinical data, trial operations and regulated processes must operate within established quality and regulatory frameworks.
The Technology Quality Specialist I supports these requirements by helping ensure technology solutions remain appropriately validated, controlled and compliant throughout their lifecycle.
The role can provide experience across CSV/CSA, GxP compliance, technology quality assurance, risk management, audits, CAPA, change control and clinical trial technology.
Benefits of the Opportunity
The job description does not specify a detailed compensation or benefits package. However, the role offers professional exposure to:
- Global clinical research and drug development operations.
- Technology quality and GxP compliance.
- Computerized System Validation and Computer Software Assurance.
- Clinical trial technology lifecycle management.
- Audit and inspection readiness.
- Quality risk management.
- Cross-functional and global stakeholder collaboration.
- Regulatory requirements governing computerized systems.
Actual salary, employee benefits and employment conditions should be confirmed directly with Parexel during the recruitment process.
How to Apply
