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QA MANAGER

Job Title: QA MANAGER
Contract Type: Permanent
Location: Central - Selangor
Specialisation:
Industry: Manufacturing
Job Reference: 42555
Contact Details: Christy Ko
Contact Email: christy.ko@jac-recruitment.com
Published: about 15 hours ago

JOB RESPONSIBILITIES

  • Planning and execution of QA strategies and procedures to assure compliance with all applicable regulatory requirements, quality system and current good manufacturing practice (cGMP) requirements.
  • Daily management and coordination of the quality function to meet ongoing customer requirements.
  • Developing and maintaining the quality system & documentation to ensure compliance with quality requirements
  • Resolving all quality matters and monitor the quality system to comply with relevant standard and regulatory requirements.
  • Is appointed as Management Representative for ensuring all requirements outlined in this quality manual are effectively implemented and maintained.
  • Responsible to deal with any government regulatory agencies, industries associations, research institute or laboratory and standardization bodies on quality matters.
  • To lead and motivate QA/QC team and lead validation team on shelf life study of finished products and validation on new products/machine/software.

JOB REQUIREMENTS

  • Possess Bachelor’s Degree holder in any Science field.
  • Minimum 5 years experiences or equal position in quality management in manufacturing of medical/ pharmaceutical.
  • Good knowledge on quality tools (7QC basic tools, SPC, 6 sigma, 8D report, FMEA).
  • Knowledge in ISO 9001. ISO 13485, ISO 14971, FDA, validation process and audit experience is a must.
  • Strong analytical, problem solving and decision making.
  • Able to work independently and lead a team.