Job description
Poseidon Adria Health Innovations d.o.o. , a branch company of Poseidon CRO group, active in the field of health, medical and pharmaceutical research and pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe , we are looking for our Quality Management Associate
Job Summary :
Responsible for the Clinical Quality Assurance functions and the over all quality management of the processes within the organization reporting directly to the CEO . Ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted by Poseidon CRO in Europe , Asia and Africa.
To lead a team focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agencies regulations, GxP, Industry Guidelines, local regulations, along with Poseidon CRO' Clinical policies and procedures for the conduct of clinical trials. This involves working closely with Clinical Operations, Information Technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities
Main responsibilities :
This opening is for graduates from Biochemistry, Medicine and Pharmacy, with minimum two to three years of experience in Regulatory Affairs in CRO or Pharma organizations.
- Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at Spaulding Clinical.
- Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits.
- Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.
- Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.
- Assist with management of contract auditors.
- Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.
- Maintain current the pool of validated vendors in differents areas as IT, central biology , biometry and logistics services
- Assist in providing training to Poseidon CRO staff.
- Participate in the review and installation of technology products and equipment
- Review vendor supplied data and quality records for conformance and good documentation practices (GDP).
- Support special projects requiring QA input.
- Perform other related duties as assigned.
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of persons assigned to this function.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- At least 3 years experience in the Pharmaceutical Industry and or Medical Device Industry with an in-depth knowledge of EU , European non EU and International regulatory and compliance standards, GxP Guidelines for pharma, medical devices and IVDs , with focus on the conduct of clinical trials.
- 3+ years working in a Quality Control / Assurance area.
- ASQ, Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation highly desirable.
- Experience including external/CRO, clinical/regulatory and document auditing highly desirable.
- Knowledge of the ISO standards 9001 and 27001
- Excellent interpersonal and communication skills.
- Knowledge of validation procedures for IT tools
- Ability to work under pressure, excellent time management and problem-solving skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint required; experience using planification and communication tools to facilitate team interaction and collaboration is preferred
- Proficiency in English (both oral and written skills).
We are very excited to read your application.
Send us your CV and Motivation Letter and references at the address : jobs@poseidoncro.com before January 27,2025, we look forward to speaking with you about this impactful position.
