Analista Senior de qualidade em pesquisa clínica temporária por 5 meses

Senior Clinical Research Quality Analyst (5-month temporary role) - Location: São Paulo - Brazil

Hybrid (2x at Cidade Jardim´s office)

Type: 5-month temporary role

Who We Are

Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science when it comes to solving the challenges of our clients' projects in a focused and exclusive fashion.

Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society.

Basic Functions and Responsibilities includes, but are not limited to:

▪ To coordinate the preparation, review, approval, and maintenance of all Intrials

Quality Management System (QMS) documentation, including SOPs, Policies, and

other controlled documents, as required.

▪ To review and support the implementation of quality processes to ensure that clinical

trials conducted by Intrials are performed in compliance with applicable regulations,

ICH-GCP guidelines, study protocols, and Intrials' or Sponsor's (SOPs).

▪ To prepare the Vendor Qualification process according to Intrials’s SOP and client

expectations (internal and external).

▪ To plan, coordinate, and participate in internal and external audits, sponsor audits,

and regulatory inspections, providing quality support before, during, and after the

audit or inspection process if applicable.

▪ To coordinate the onboarding quality process for new employees, ensuring

completion of mandatory Quality Management System and GxP training

requirements.

▪ To manage the Quality Management System (QMS), ensuring its maintenance,

continuous improvement, and compliance with applicable regulations and company

procedures.

▪ To act as System Owner for the electronic Quality Management System, ensuring

its proper administration, maintenance, user support, and compliance with validated

state requirements.

▪ To support the validation and lifecycle management of computerized GxP systems,

ensuring compliance with applicable regulatory requirements and internal

procedures.

▪ To manage the deviation process, including deviation review, investigation

oversight, root cause analysis, CAPA definition, and effectiveness follow-up.

▪ To provide Quality Assurance guidance to internal departments regarding GxP

compliance, quality processes, and regulatory requirements.

Primary Activities includes, but are not limited to:

▪ To lead the vendor qualification and requalification program, including qualification

assessments, vendor audits, audit reporting, and ongoing performance monitoring

in accordance with Intrials' Quality Management System (QMS) and applicable

regulatory requirements.

▪ To plan, coordinate, perform, and report internal and external quality audits,

including site audits, Trial Master File (TMF) audits, process audits, and vendor

audits, ensuring compliance with ICH-GCP, applicable regulations, sponsor

requirements, and Intrials' SOPs.

▪ To support and participate in sponsor qualification audits, regulatory inspections,

and client audits, serving as the primary QA representative and coordinating audit

logistics, documentation, and responses.

▪ To coordinate the management of audit and inspection findings by leading root

cause investigations, reviewing and approving CAPA plans, monitoring

implementation, verifying effectiveness, and ensuring timely closure.

▪ To support the development, review, and negotiation of Quality Agreements with

sponsors, vendors, and other business partners to ensure alignment with regulatory

and contractual quality requirements.

▪ To manage and continuously improve the Intrials Quality Management System

(QMS), ensuring that quality processes remain effective, compliant, and aligned with

applicable regulations, ICH-GCP E6(R3), and industry best practices.

▪ To develop, review, maintain, and implement controlled quality documents,

including SOPs, Policies, Work Instructions, templates, and other QMS

documentation.

▪ To develop and deliver GCP and Quality Management training programs, ensuring

personnel maintain the competencies required for their assigned responsibilities.

▪ To promote a culture of continuous improvement by identifying quality risks,

analyzing quality metrics and trends, recommending process improvements, and

supporting the implementation of risk-based quality management initiatives.

▪ To maintain current knowledge of applicable regulations, ICH-GCP guidelines, and

GCP requirements by participating in professional development activities, training

programs, and scientific meetings, applying acquired knowledge to strengthen the

organization's Quality Management System.

▪ To coordinate the Quality onboarding process for new employees, ensuring

assignment and completion of mandatory training within established timelines.

▪ To manage deviations, non-conformities and quality events, including review of

investigations, root cause analysis, CAPA implementation and effectiveness

verification.

▪ To review deviation investigations to ensure completeness, technical adequacy and

compliance with company procedures and regulatory expectations.

▪ To perform periodic monitoring and trending analysis of Quality Management

System metrics and quality indicators.

▪ To act as System Owner for the electronic Quality Management System (eQMS),

including user administration, workflow configuration, change requests, issue

management and liaison with the software vendor.

▪ To support computerized system validation activities, including validation

documentation review, risk assessments, change control evaluation, periodic review

activities and maintenance of the validated state.

▪ To support periodic reviews of validated computerized systems to ensure continued

compliance with GxP requirements.

▪ To participate in Change Control activities related to quality processes and

computerized systems.

▪ To ensure Quality records are properly maintained, archived and readily available for

audits and inspections.

▪ To support the preparation, review and implementation of Quality Metrics and

Management Review reports.

▪ To identify opportunities for continuous improvement and lead Quality initiatives to

optimize processes and increase QMS effectiveness.

▪ To provide Quality support during implementation of new processes, procedures and

computerized systems.

Skills:

• Degree in health science area (Pharmacy, Biology, Medicine, Nutrition, etc);
• Knowledge of Clinical Trial Regulations;
• Reliable professional training;
• Good interpersonal relationships;
• Good knowledge of GCP and ICH requirements guidelines;
• Good knowledge of Quality Assurance processes, activities, tools;
• Computer skills on Windows environment and Microsoft Office tools;
• Experience in structuring quality SOP´s.
• Advanced English; Mandatory to understand and speak
• Preferably knowledge of oral and written Spanish (not mandatory)