Quality Assurance Specialist/Lead at ClinChoice

Yerevan, , Armenia -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, CAPA Management, Deviation Management, Internal Audits, External Audits, Risk Management, GXP Requirements, GCP, Problem-Solving, Microsoft Office, Clinical Operations, Regulatory Requirements, Stakeholder Management, Root Cause Analysis, Impact Analysis, Effectiveness Monitoring

Industry

Pharmaceutical Manufacturing

Description

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an CAPA Manager on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Main Job Tasks and Responsibilities: Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals including stakeholder management for closure of CAPAs. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Education and Experience: Bachelor’s or Master’s degree in Life Sciences (e.g., Biochemistry, Biology, Pharmaceutical Sciences) or a related field. 5 to 8 years of professional experience in the Life Sciences domain. Proven expertise in Quality Assurance and Nonconformance Management, including handling CAPAs, Deviations, and Issue Management. Working knowledge of GCP (Good Clinical Practice) principles is a plus. Solid understanding of global regulatory requirements and industry standards (e.g., cGMP, ICH, FDA, EMA). Proficient in English, both written and verbal. Strong problem-solving capabilities, with a structured approach to addressing compliance and operational challenges. Proficiency in Microsoft Office (e.g. Word, Excel, Outlook). Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Responsibilities

The Quality Assurance Specialist/Lead will perform QA functions related to change management, CAPA, deviations, and audits. They will ensure compliance with GXP requirements and facilitate the initiation and closure of CAPAs.