Quality Assurance Specialist

23 hours ago


Klang, Selangor, Malaysia Rieckermann Full time

**Job Overview**

We at Rieckermann Malaysia are on an exciting journey of growth and development. Our team is seeking a dynamic Quality Assurance Specialist to join our Engineering Operations (EO) portfolio, helping us achieve our vision to become the leading industrial solution provider in our core markets.

About Us

Rieckermann is a privately-owned group of companies providing international industrial solutions. We have more than 750 employees at 24 offices in 17 countries spanning Europe, Asia, and the Middle East. Our service portfolio covers the entire value chain and scope of industrial plant development in 9 industry sectors.

Key Responsibilities

  • Sourcing, specification, and selection of new equipment based on minimal user input
  • Coordinating with vendors and working with design teams to ensure a fit-for-purpose system
  • Managing installation and commissioning of equipment (with vendor support)
  • Qualification of equipment, including preparation of protocols and test plans, execution of protocols, sample and reagent preparation, qualification summary reports, and deviation investigation
  • Supporting process technical transfer, including feasibility studies, equipment sizing, process design, process validation, and process optimization
  • User training in equipment use and operation
  • Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance

Requirements

  • University degree in Engineering, Life Sciences, or equivalent
  • Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
  • Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
  • Experienced working under Quality Management Systems
  • Excellent interpersonal and communication skills
  • Goal-oriented, dynamic, and high sense of responsibility
  • Able to work flexibly and under pressure
  • Able to work self-reliantly
  • Possess excellent customer-oriented work-ethic
  • Professional appearance and demeanor
  • Very good written and verbal English skills

* This role is available for all levels, employment will be permanent or fixed-term contract roles depending on project *



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