Senior QA Engineer (12 months)

Job Summary:

To handle customer complaint / feedback and lead internal investigations to identify complaint root cause and CAPA’s. Host customer audits. Lead quality improvement projects.

Essential Duties and Responsibilities:

• Responsible for providing support to Customer QA Manager to ensure daily, weekly and monthly KPls are achieved

• Manage customer complaints ensuring timely and accurate response

• Host customer audits and act as the company spokesperson during the audit

• Provide response to customers enquiries and chair meetings requested by customers on complaints

• Lead the internal investigation with relevant departments to identify root cause for customer complaints / audit findings

• Establish CAPA for the identified root causes together with the relevant departments

• Ensure that the CAPA’s are implemented on time and able to effectively address the root causes of the issue

• Drives a right-first-time culture by routinely analyzing complaints and audit trends to identify improvement opportunities

• Lead product quality and quality system improvement projects

• Is a champion of A4 and A3 problem solving and systematically put these methodologies into use to identify root cause of complaints and audit findings. Coaches and mentors plant team to build capability in the area.

• Supporting internal and shop floor audits, as required

• Lead/supports process improvements, cost reductions/savings, intermix prevention, contamination control, scrap reductions, quality improvements etc. through the implementation of LEAN concepts (including the use of the Kaizen suggestion system).

• Encourage and foster teamwork within the plant team

• Prepare reports timely to highlight QA statistics

• Train and coach junior engineers

• Support QA and Customer QA Manager to maintain the ISO 15378 / 9001 system

• Any other duties as assigned by QA and Customer QA Manager.
  

Basic Qualifications:

• Bachelor’s degree or equivalent experience in Engineering / Science

• At least 5 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment

• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards

• Good knowledge of cGMP requirement and strong quality mindset

• Familiar with primary packaging materials manufacturing processes and requirements

• Effective communication and interpersonal skills

• Strong excel and report development skills

• Strong analytical skills

• Ability to work independently

• Strong learning capacity
  

Preferred Knowledge, Skills and Abilities:

• LEAN Six Sigma Green or Black Belt

• Certified Internal or Lead Auditor

• Quality Engineer certification is a plus

• Project Management certification is a plus

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

• Support and contribute in Lean Six Sigma programs and activities towards delivery of the set target

• Able to comply with the company’s safety policy at all times

  • Highlight unsafe practices to responsible persons

  • Proper use of Personal Protective Equipment (PPE)

  • Work safely by not causing unsafe conditions or doing unsafe acts

• Able to comply with the company’s quality policy at all times.

  • Work in accordance to the local and global procedures

  • Compliance to GMP requirement