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Pharmaceutical & Medical Services
16 Jun 2017
Job Opportunity : Thailand Quality Manager (110K)
Position
Thailand Quality Manager
Our Client
One of the Leading International Pharmaceutical Firms
Location
Bangkok
Report to
ASEAN Quality Manager

Responsibilities:

  • Be responsible for product quality related matters, escalate any local product quality related issue to the ASEAN Quality Manager, Regional Quality Leader and the affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
  • Implement and monitor product quality systems and Quality Manual in the Marketing affiliate.
  • Assist affiliate management, ASEAN Quality Manager and Regional Quality Leader in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards, GQP and local regulations.
  • Execute the assessment plan for GMP Service Providers.
  • Create and revise Quality agreements covering affiliate processes for GMP service providers.
  • Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
  • Ensure affiliate compliance with Good Manufacturing Practices (GMP), Good Warehousing practices, GQP and good Local testing practices for finished products. Also ensure affiliate compliance with all relevant local regulations.
  • Ensure products received comply with the market authorization, by approving/rejecting batches.
  • Where QC testing of API (Active Pharmaceutical Ingredient) is a local regulatory requirement, ensure Good Laboratory Practices (GLP) is followed
  • Maintain local procedures which reflect local regulations (where required) and corresponding global quality standards.
  • Develop and execute the Quality plan to correct and prevent recurrence of significant quality problems from audits, self-inspections, deviations, recalls, product complaints or significant changes
  • Ensure compliance to the Affiliate Quality Manual, other applicable company quality standards, GQP and relevant local regulations by completing quality system maintenance activities by target due dates
  • Assess GMP suppliers and service providers where applicable according to an approved plan.
  • Facilitate and co-ordinate Regulatory Agency inspections, EGQCA audits of the affiliate and service providers. Support the affiliate with the audit readiness plan. Take daily notes and report the daily audit activities to the affiliate Lead Team.
  • Review and consult on all new business deals that require quality operations with the ASEAN Quality Manager and Regional Quality Leader
  • Document in agreement with the ASEAN Quality Manager and Regional Quality Leader, any potential regulatory reportable event as a result of a product defect. Ensure adherence to reporting timelines.

 

Qualifications:

 

  • At least 3-5 years Quality experience in a GMP environment
  • Inventory management knowledge highly regarded
  • Understanding of local regulations in each region
  • Strong organization and planning skills
  • Ability to prioritize and manage competing tasks and timelines
  • Excellent interpersonal and communication (written and oral) skills
  • Good command of English