Technology Quality Specialist I

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🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Quality Specialist

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Act as a Quality Representative, custodian and leader of the Parexel Quality System, and ambassador for quality across the business and with customers • Support development, implementation and management of Parexel strategic objectives • Establish and maintain communication frameworks for timely and effective action on quality matters • Perform general and administrative tasks, including accurate and timely completion of TIME • Collaborate with functional leads to design, re-engineer, implement and adopt quality frameworks for validation and release of interfaces and solutions • Lead activities to identify risk and value improvements for process architecture, including Standard Operating Procedures, policies and adjunct documentation • Support development, implementation and continuous improvement of training and adoption programs focused on infrastructure, change control and problem management processes • Provide guidance, consultation and expertise to project teams throughout clinical trial and validation lifecycles • Monitor compliance status and activities to maintain compliant states for technologies, business areas or portfolios • Support identification of requirements for validation deliverables, including planning, resource estimates, risk and impact assessments, summary reporting and electronic records/signature regulations • Assist with risk mitigation, risk categorization and mitigation planning • Support third-party supplier audits by reviewing vendor validation packages and ensuring adequacy • Support technology-related Quality Issue management, including issue description, classification, root cause analysis and corrective/preventive actions • Support Change Control Board members in authorizing or rejecting change requests from a technology quality and validation perspective • Support audit and inspection hosts with planning, coordination and standard presentations covering Technology Solution Life Cycle and general IT areas • Assist with collation and finalization of audit responses • Provide quality and GxP regulatory advice for technologies used in trials or trial programs • Support development of risk management processes aligned with industry best practices and standards • Support Requests for Information and proposal activities by reviewing and updating information to align with quality and compliance standards

🎯 Requirements

• Entry-level experience in Computer Technology Quality & Compliance, including Computerized System Validation (CSV/CSA) within the pharmaceutical and life sciences industry • Understanding of Clinical Drug Development processes across Phase I, II, III, and IV studies, as well as manufacturing operations in regulated GxP environments • Working knowledge of FDA regulations, EU regulations, and ICH guidelines related to validation, compliance, and assurance of computerized systems in GxP-regulated areas • Understanding of GAMP 5 principles for the validation and assurance of computerized systems, including emerging AI-enabled applications • Basic knowledge of continuous improvement methodologies and quality-driven process enhancement initiatives • Competence in core project management activities, including planning, coordination, tracking, and execution support • Strong interpersonal, verbal, and written communication skills • Good business acumen, organizational, stakeholder management, and negotiation skills • Ability to work effectively in a customer-focused, fast-paced, and dynamic environment while managing multiple priorities and deadlines • Self-motivated professional with a proactive approach to learning and continuous development • Strong sense of ownership, urgency, and commitment to resolving issues and meeting project objectives • Cultural awareness and ability to collaborate effectively in global environments • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat PDF, and other standard desktop productivity tools • Ability to work independently with appropriate guidance while maintaining compliance, quality, and operational excellence standards • 2–3 years of relevant experience • Entry-level clinical trials and/or research work experience required, with emphasis on GCP and technology compliance • Familiarity with technology related to clinical trial activities, including System Life Cycle processes and applicable GCP regulations pertaining to Computer Systems • Entry knowledge of project management, Lean Six Sigma, auditing and/or risk management methodologies • Educated to degree level (technology, biological science, pharmacy or other health-related discipline preferred) or equivalent qualification

🏖️ Benefits

• Full-time employment