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09 December 2019
Job ID: CH-11948
Quality Management System Specialist (Pharmaceutical, Food, FMCG)
Responsibilities:
  • Providing hands-on technical expertise in terms of resolving issues and identifying risks. This may include providing recommendations regarding appropriate actions and evaluations of resources required.
  • Using a systematic approach to managing quality improvements and resolving daily quality issues. Also, working with the QRM Director who will be responsible for establishing specific quality measurements and direction.
  • Ensuring that within the quality operations area the QMS is followed and standard work is implemented and maintained, and follows all quality system requirements.
  • Ensuring regulatory and good manufacturing practice compliance as outlined in the quality manual, policies and procedures.
  • Managing the total supplier quality process including supplier approval and inspection of incoming raw materials.
  • Interfacing with all organizations in the plant to review policies and procedures, regulations, and work instructions.
  • Participating in internal, external, customer, and supplier audits, and regulatory inspections.
  • Providing GMP guidance to the facility.
  • Regularly researching and evaluating regulatory trends to ensure compliant systems.
  • Reviewing regulatory, program, and customer requirements, ensuring early quality involvement in program development.
  • Maintaining audit programs and management reviews, and providing reporting results to management.
  • Maintaining complaint files and corrective & preventive action systems.
  • Facilitating communications between functions and multi-facility groups.
  • Performing various other related duties of similar types and work as assigned. 
Qualifications:
  • Bachelor’s Degree or higher in an engineering field, or equivalent industry experience.
  • At least 8 years' experience in quality management systems / quality assurance jobs, especially work relating to compliance and visiting customers.
  • A comprehensive understanding of quality system requirements and processes within manufacturing operations is required.
  • A certified Internal Auditor.
  • Knowledge and experience of GMP, GDP, and FDA standards, ISO13485 and ISO14971.
  • Knowledge of corrective & preventive action programs base on 8D methodologies.
  • Good interpersonal and communication skills.
  • Very good English communication skills (reading, writing and speaking).
  • Willing and capable to work with cross-functional teams. 
Our client offers a basic salary, a housing allowance, provident fund, group insurance, a fixed and variable bonus, and a five day working week. 

Reference Code: QM1100212
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Job Details:

PRTR Recruitment and Outsourcing (Eastern Seaboard) Co., Ltd.
https://www.prtr.com/
Our client is a leading global manufacturer of automotive parts.
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