Prime Services CRO is inviting applications for the Clinical Systems Quality Assurance (CQA) role. The position focuses on quality oversight of clinical software systems, computerised system validation (CSV), software quality assurance, data integrity, and regulatory compliance across clinical research systems.
The selected professional will support validation documentation, user acceptance testing (UAT), audit readiness, change control, deviation management, and quality oversight of clinical technology platforms, including eTMF, CTMS, EDC, and IWRS/RTSM.
Job Details
| Particulars | Details |
|---|---|
| Company | Prime Services CRO (MERIL) |
| Position | Clinical Systems Quality Assurance (CQA) |
| Job Category | Clinical Quality Assurance |
| Qualification | Bachelor’s or Master’s Degree |
| Eligible Disciplines | Life Sciences, Pharmacy, Biotechnology, Computer Science, Healthcare or related disciplines |
| Industry | Clinical Research / Healthcare |
| Application Mode | |
| Contact Email | dolly.sakariya@primeservicescro.com |
Positions
Prime Services CRO is hiring for the following role:
– Clinical Systems Quality Assurance (CQA)
Key Responsibilities
Candidates selected for the Clinical Systems Quality Assurance role will be responsible for:
1. SOP Development and Review: Work on SOPs covering software development, validation, access management, change control, incident management, backup, and recovery.
2. Validation Documentation Review: Review User Requirement Specifications (URS), validation plans, test scripts, validation evidence, traceability matrices, and validation reports.
3. User Acceptance Testing: Coordinate UAT activities with clinical teams.
4. Clinical Systems Quality Oversight: Review user access, audit trails, electronic signatures, data integrity, and document controls.
5. Clinical Software Systems: Provide quality oversight for eTMF, CTMS, eCRF/EDC, and IWRS/RTSM platforms.
6. Deviation and CAPA Management: Track deviations, defects, Corrective and Preventive Actions (CAPAs), and change controls.
7. Audit and Inspection Readiness: Support audits, vendor assessments, and inspection-readiness activities.
8. Release Readiness: Verify documentation and training requirements before providing release-readiness recommendations.
Eligibility and Qualifications
Applicants must have a bachelor’s or master’s degree in one of the following disciplines:
- Life Sciences
- Pharmacy
- Biotechnology
- Computer Science
- Healthcare
- Related disciplines
Required Skills and Preferred Exposure
Candidates with exposure to the following areas are preferred:
- Clinical Systems
- Computerised System Validation (CSV)
- Software Quality Assurance
- Good Clinical Practice (GCP)
- Software Development Life Cycle (SDLC)
- Risk-Based Validation
- Data Integrity
- Electronic Records and Electronic Signatures
Essential professional skills:
- Strong documentation skills.
- Attention to detail.
- Objective review and assessment mindset.
- Effective communication and follow-up.
- Ability to identify and escalate unresolved quality issues.
Application Details
Interested and eligible candidates can share their updated profiles using the following contact details:
| Application Details | Information |
|---|---|
| Company | Prime Services CRO |
| Position | Clinical Systems Quality Assurance (CQA) |
| Application Email | dolly.sakariya@primeservicescro.com |
