**GCP Quality Auditor - South Korea - Global Company**
Company: Advanced Clinical Recruitment Ltd
Location: South Korea
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary & Package
I am working with a leading Global company, who are actively looking to make additions to their Quality team, based in South Korea! You will be located in a suburb of Seoul, working for a group with a fantastic Global name in the up and coming APAC market. My client will look at professionals from a GCP background, and not necessarily requiring Audit experience. You will receive excellent training, and join a growing team, where the opportunity for progression is very realistic.
The Clinical Quality Assurance Auditor will assist with the development and maintenance the infrastructure to support Clinical Quality System within the Company.
This role will report to Senior Clinical Quality Assurance Auditor and possibly doted line for Clinical Quality Assurance Group Leader for assigned job.
- Be responsible for or paticipate in developing and managing risk assessments, CAPA, metrics, etc under supervision of Senior Clinical Assurance Auditor or designee
- Be responsible for gathering and interpreting regulatory intelligence, as well as proposing internal practices, making recommendations for improvement against action plans to Clinical Quality Assurance Group. Execute assigned improvement activities under supervision of senior Clinial Quality Assurance Auditor or designee.
- Exercise judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.
- Create, review and/or supervise company documents including SOPs required for the proper functions, groups or teams of clinical trial process and of post marking servailence process if applicable. To ensure that all SOPs, once created are evaluated and updated on a continuing basis at regular pre-set intervals.
- Appropriately escalate any noncompliance issues and be involved in the investigations of suspected serious noncompliance if applicable.
- Schedule, conduct, and document assigned audits of projects and operational processes in accordance with approved procedures, schedules, and formats.
- Assist, perform, and/or manage relevant internal audits and maintain status tracking of internal audits under supervision of senior Clincial Quality Assurance Auditor or designee
- Perform in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics under supervision of senior Clincial Quality Assurance Auditor or designee
- May draft and issue periodic reports to quality management as requested by Clinical Quality Assurance Group Leader
- Participate in the development, implementation, and maintenance of internal Quality System, including facilitating process innovation activities to the product and project teams for continuous improvement.
- Perform training and orientation activities for new and exsiting staff of Clincial Quality Assurance Group and for relevant team members within the company.
Sub-role(s) assigned by Director, CQA
1) Auditors specialized into GCP, GVP, and/or System in general.
- Prior to assign the speciality of audit area, group members should be assigned to ‘Audit Trainee’.
- GCP auditor: Be familiar with GCP and relevant regulations/guidelines, and perform the relevant audit activities in company level as an independent auditor, when assigned.
- Be familiar with PV systems, procedures and relevant regulations and set a PV annual plan and perform the relevant PV audit activities in company level as an independent auditor, when assigned.
- Be familiar with vendor and/or system requirements and relevant regulations and set a annual plan and perform vendor and/or system audit activities in company level as an independent auditor, when assigned
2) Internal compliance:
- Document coordinator: Coordinate and review the creation of company documents and systems including SOPs required for the proper functions, groups or teams of clinical trial process and of post marking servailence process if applicable. To ensure that all SOPs, once created are evaluated and updated on a continuing basis at regular pre-set intervals.
Knowledge & Skills
- Bachelor’s degree in a biomedical, pharmacy, or life sciences
- Demonstrated competence in clearly and fluently expressing concepts and ideas orally and in writing in the officially recognized language, English
- Behavioral Competency
- Analytical Thinking
- Conceptual Thinking
- Information Seeking
- Team Work & Cooperation
- Training & Development
- CQA Audit Trainee or Document Coordinator - (If not having more than 2 years experienced in clinical monitoring or project management roles previously)
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
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