- Type
- Contract
- Experience
- 25+ years
- Closing date
- Today
- Source
- ApplyToJob
Description
We’re looking for a detail-oriented Quality Specialist to manage SOPs and Sponsor documentation, support quality systems and supplier qualification activities, deliver Sponsor quality services, and monitor KPIs/KQIs to ensure compliance and quality objectives are met.
Key Responsibilities:
Requirements:
What we offer:
Who we are
OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.
Key Responsibilities:
- Manage SOPs, controlled documents, and Sponsor quality documentation within the QMS.
- Conduct compliance reviews of study documentation, systems, and training records.
- Provide GCP/GxP quality support and escalate compliance issues as needed.
- Support CAPA management, audits, inspections, and audit readiness activities.
- Perform vendor, site, and study audits, and manage supplier qualification processes.
- Support quality services, risk assessments, and maintenance of GCP/GxP and ISO-certified quality systems.
- Coordinate quality training and monitor quality metrics (KPIs/KQIs) to drive continuous improvement.
- Ensure timely completion of training, documentation, and administrative requirements.
- Perform additional quality and compliance-related duties as assigned.
Requirements:
- Bachelor’s degree, preferably in Life Sciences or a related scientific field.
- Strong English communication skills.
- Proficiency in Microsoft Office applications.
- Excellent planning, organizational, and time-management skills.
- Strong interpersonal skills with the ability to work collaboratively in a cross-functional team environment.
What we offer:
- Competitive Salary
- Collaborative international environment
- Opportunity to work on impactful clinical research projects
- Professional growth and continuous learning
- Dynamic role combining technology and healthcare innovation
Who we are
OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.
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Skills
GCPCompliance
