Sr Quality Specialist

Job Location(s) PH-Manila
Job Number
Job Category
Drug Safety/Pharmacovigilance
Position Type

Job Overview

- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.
- Ensure compliance of operations with governing regulatory requirements.
- Create, maintain and assume accountability for a culture of high customer service.
- Nurture and sustain an environment of continuous learning.
- Perform Quality review of assigned calls/cases.
- Assist in compiling quality metrics based on this review and identifying quality trends, addressing periodic client quality reviews.
- Assist in preparation of Corrective and preventive actions as requested.
- Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers
- Assist in the conduct of process review for assigned process and measure and monitor audit readiness
- Assist in designing and tracking training schedule and training material for new hires and existing team
- Contribute to discussion forums on Quality errors within assigned project and help identify process improvements
- Assist in coordinating respective client or external audits of the assigned projects as requested
- Assist in development of Quality Management Plan for assigned project

- Coordinate with the project team to support the Client during regulatory inspections
at client sites with support from Quality Lead / Quality Manager.


- Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science.


- 3 plus years of overall work experience in the functional area with at least 1 year’s experience in Peer review/Quality review and experience in CAPAs and quality trending.
- Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports.


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