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QA Manager (Pharmaceutical)

  • Location: Thailand
  • Salary: THB140000 - THB141000 per month per month
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Supply Chain & Technical
  • Contact: Atthawut Pariyarungsi
  • Expiry Date: 07 September 2022
  • Job Ref: JN -082022-472790

Salary: Up to 130K with other benefits per month

*** This position is for Thai candidates only. ***

About our client

Our partner is a leading global pharmaceutical company. They are famous for being one of the top innovative medicine producers & providers with ambition to be number one in the market. Currently, they are looking for an experienced QA Manager to lead and develop their QA team.

Key responsibilities

  • Act as a representative and QA contact point of Thailand for all product quality and to make sure all the practices align well with the standard
  • Maintain sustainable product quality system and quality culture at the company, ensuring compliance with GMP, GDP and regulatory authority expectations
  • Investigate all product quality issues in the PCO and for interacting with the relevant stakeholders (such as Regulatory Affairs, Global Supply Chain, Medical, Commercial BU) and PGS on such issues
  • Monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and external regulatory GMP/GDP inspections
  • Responsible for the quality release of compliant product into Thailand market and Indochina export markets (Cambodia, Myanmar, Laos) ensuring adherence to GMP/GDP for medicinal products
  • Drive and direct ongoing education on quality to relevant PCO functional groups, to develop awareness and comprehending requirements and enhance the quality culture
  • For product quality system, deploy implementation of SCQ functional and global SOPs and the company's quality standard requirements. This includes but is not limited to ensuring all relevant PCO colleagues are appropriately trained
  • Gauge PCO quality performance and present metrics in management quality review
  • Ensure effective management of quality systems such as commitment tracking and change control. Ensure timely completion of actions
  • Lead quality risk assessment and apply quality risk assessment tools as necessary
  • Lead cross-functional investigation team for deviations that occur within the responsibility of SCQ organization, drive agreement, tracking of corrective/preventive actions and ensure CAPA effectiveness
  • Ensure effective processes to meet all required complaint handling timelines and notification requirements. Manages the intake, triage and response to the complainant in a timely manner
  • Lead implementation of actions identified from Area Quality Review Team (AQRT) or Enhanced Quality Review Team (eSQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions
  • Lead local market action team and ensure effective completion of all required actions i.e. recall
  • Drive stakeholder value as market responsible person
  • Responsible for inspections and internal audit and local product disposition and local contractor quality oversight

Key requirements

  • Bachelor's Degree in Pharmacy
  • Over 6 years of experience in Pharmaceutical or Healthcare background with commercial quality practice
  • Strong experience and application in Quality Management system
  • Strong experience and application of current Good Manufacturing Practice/ Good Distribution Practice
  • Ability to negotiate the internal stakeholders and relevant external institutions
  • Ability to interpret and analyze data with strong problem-solving skills
  • Able to manage complex situations and see things in a big picture with logical implementations
  • Excellent written and verbal communication in both Thai and English

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.