| Job Location | Dubai, United Arab Emirates |
| Education | Bachelor's degree / higher diploma |
| Salary | Not Mentioned |
| Industry | Pharmaceutical |
| Functional Area | Not Mentioned |
Associate ? Clinical Quality:?Will be responsible for the Late Phase Clinical Trials Quality Control functions of the organization, reporting to the Manager-Clinical Quality at USA. Ensuring that planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of Clinical Trial studies.Will have to aid continuous improvement of projects using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, industry guidelines, local regulations, along with Company?s clinical policies and procedures for the conduct of clinical trials.This involves working closely with teams from clinical operations, information technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.?Pre-requisite:? Bachelor?s Degree or equivalent experience in associated functional discipline.? At least 1 years? experience in the Pharmaceutical Industry and or Medical Device Industry with an in-depth knowledge of US, EU and International regulatory standards, and GxP Guidelines for the conduct of late phase clinical trials.? Over two years of work experience in a Clinical trial Quality Control / Assurance area.? Auditor, Clinical Trial Associate or Clinical Trial Manager accreditation is highly desirable.? Pior Experience in external/CRO, clinical/regulatory and document auditing is highly desirable.? Preferred Age Group: Between 25 to 32 yearsKey Responsibilities:? Assist in developing and maintaining GCP/ICH compliant processes which control the quality of work and clinical trials conducted.? Actively lead or assist activities in the areas of Internal Quality Control and Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits.? Lead quality control activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.? Lead or assist with identifying non-conformances (non-compliance?) 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 ever 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.? Assist in training the Clinical staff.? Participate in the review and installation of technology products and equipment.? Be willing- to travel? Review vendor supplied data and quality records for conformance and good documentation practices (GDP).? Support special projects requiring QC input.? Perform other related duties as assigned.
Keyskills :
Clinical ResearchClinical Trials
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