Vigilance and QRA Specialist

An exciting Vigilance and QRA Specialist (x1 vacancy) job has just become available at one of the most respected global medical supply company (MNC).

About the Vigilance and QRA Specialist Role:

In this business-critical role, you will be responsible for managing Healthcare Quality and Regulatory Affairs (QRA) function. Reporting directly to the Environment & Quality Assurance Manager, this is a role for a medical device specialist who is a leader in their field. Salary Field: THB60k - 75k++ per month + allowance + bonus + provident fund + insurance

Key Responsibilities:

• Manage healthcare QRA function in Thailand: Implement and manage Thailand ‘s regulatory & quality affairs in alignment with local regulatory and local & global requirements as well as quality strategy plans and processes
• Ensure Q&RA program and processes are implemented and carried out accordingly as well as implement quality policies for development, manufacturing, distribution, post-marketing processes (vigilance etc.) and services including direct delivery to patients within the country
• Assist and support QRA activities of the cluster country (Thailand)
• Internal networking with the country stakeholders (HC, Operations, CSC, Legal and Regional HC) to ensure input and buy in to the HC QRA agenda and to promote understanding of HC QRA at all required levels of the organisation
• Act as the key point of contact with the regional QRA function; provide input into regional QRA initiatives
• Responsible for the GMP, vigilance and quality system training program in Thailand which will be run together with business processes and operations
• Execute and follow up in-country audit program
• Lead and manage the medical quality panel
• Assist in the investigation of all HC related incidences
• Be responsible for the compliance in Thailand; including local regulatory requirements and internal minimum requirements
• Act as the contact person for Thailand’s local regulatory authority
• Secure registration approvals according to the country regulatory plan
• Third Party Agreements: Review and assure the correct handling of vigilance issues in local contractual agreements (licensors, contract research organisations, etc). Review of 3rd party vigilance agreements
• Studies:Request and perform Post Market Safety Study (PMSS); if clinical trial is conducted. Assess and track local market research and patient support programs
• Review adverse event and literature search line listings for their country on a monthly basis provided by GSV. Report any deviation identified during that review to GSV as a nonconformance
• Perform annual reconciliation of Pharmacovigilance activities for compliance to requirements
• Notifying the QPPV and/or GSV

To succeed in this role, you must have good observation and communication skills.

Key Requirements:

• Bachelor or Master Degree in Pharmacy, Health Science, Chemical or Industrial
• Minimum five years experience in an operational/manufacturing/pharmaceutical environment in quality sensitive industry (e.g. Medical Gases, Pharmaceutical, Food, Aeronautical industries)
• Knowledge in quality assurance, project & risk management or GMP would be highly regarded
• Experience or familiar to MOPH, FDA, Educational, Healthcare, Quality and Safety
• Experience or familiar to external stakeholders (regulatory authorities, industrial, educational or Physician professionalism bodies)
• English communication & international experience
• Able to travel in country & South East Asia

This leading company has an outstanding international reputation in its field. This well-recognised brand offers a great working environment.

If you are driven, determined and want to take the next step in your career, this is the role for you.

Apply today or call 023444828 to discuss more details.

Due to the high volume of applications, our team will only be in touch if your application is shortlisted.

Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551