Quality Assurance Manager (Pharmaceutical)

Location: Dong Nai, Vietnam
Job Type: Permanent
Salary Negotiable
Specialization: Life Sciences, Healthcare, Medical Devices & Pharmaceutical
Sub Specialization: QC / QA
Contact: Pham Thi Tuyen
Reference: JO-1809-402789

This role is responsible for managing workflow within and outside Quality Assurance, resolves and supports day to day events between direct reports and other operational areas related to Quality Assurance, as well as develops and implements tactical initiatives directed by Senior Management:

  • Ensures that all aspects of the manufacturing and testing of products comply with the requirements of the COMPANY Quality Manual and meet all the relevant cGMP regulatory & legislative requirements.
  • Ensures that all components, raw materials and drug substance are tested and released in accordance with the written specifications and are released to market in accordance with national/international regulations.
  • Together with site management, provides direction, develops strategies and makes decisions which ensure the efficient operation of the business.
  • Participate in establishing the Site Quality Plan with supervisor and ensures appropriate quality planning, execution and monitoring of quality objectives at the site.
  • Demonstrates strong and visible support while implementation of Quality Systems and Quality Manual and ensures effective implementation to achieve the quality objectives.
  • Ensures that the COMPANY quality commitment is communicated and understood within the site.
  • Defines and ensure implementation of QA relevant roles, responsibilities, authorities and interrelationships at all organizational levels.
  • Ensures technical release (as applicable) of bulk or finished products, APIs for production, intermediates.
  • Provides leadership, direction, training and support to the people within the QA departments and ensures that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
  • Conducts management reviews of product quality and of the pharmaceutical quality system.
  • Ensures that health and safety procedures are followed.
  • Ensures proactive risk management of site systems and operations in line with current regulatory expectations and COMPANY standards.
  • Establishes and monitors quality performance indicators that measure progress against quality objectives.
  • Establishes communication processes throughout site to ensure the appropriate and timely escalation of product quality and quality system issues, including the quality assessment process.
  • Ensures that Standard Operating Procedures are in place and that compliance with cGxP is maintained through internal auditing and training.
  • Ensures that the QA operate in a cost effective and efficient manner and maintains an innovative approach based on productivity improvement and implementation of best practices.
  • Maintains current knowledge of local and international regulatory and legislative requirements and trends to provide expert advice and appropriate technical support on all quality related matters.
  • Ensures that coordinated contact is maintained with the regulatory authorities, local partners (suppliers, third parties, licensees, distributors) and customers.
  • Manages audits, inspections (Internal / customer / Health authority), complaints, recalls, counterfeits and product tampering according to the COMPANY requirements.
  • Responsible to monitor and trend KQI (Key Quality Indicators).
  • Assist supervisor in implementations and Quality Council.

Requirements:

  • Background in Pharmacy, Master Degree is an advantage.
  • The candidate shall have minimum of 10 years' experience in a Quality Assurance role in the pharmaceutical industry.
  • Experienced in implementation and administration of quality systems in drug product development, manufacturing, packing, distribution quality control, QA operations, etc.
  • Be capable to identify and resolve issues in compliant way.
  • Quality System management experience
  • Strong written and spoken communication skills to communicate with internal & external customers and health authorities.
  • Good leadership skill