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

Senior QA Engineer (12 months)