Job Summary:
Responsible to manage a team of Senior / QA Engineers to handle customer complaints; response to enquiries; host customer audits; review customer agreements and specifications. Act as West representative when interfacing with customers.
Essential Duties and Responsibilities:
• Manage Senior / QA Engineers to handle customer complaints and provide timely resolution to customer’s issues. This includes communication with customers / commercial team to understand customer’s concerns, work with impacted departments to conduct root cause analysis, review proposed CAPA and provide timely complaint response to customer.
• Manage Senior / QA Engineers to host customer audits. This includes leading preparation work, acting as host during the audit, work with impacted departments to resolve audit findings, review proposed CAPA and provide timely audit response to customer.
• Lead internal investigation with production and other relevant departments using A3 or Six Sigma methodology to identify root cause and CAPA for customer complaints / audit findings.
• Ensure that identified CAPA’s are implemented on time and able to effectively address the root causes of the issues.
• Manage Senior / QA Engineers to review customer agreements and specifications.
• Manage cross functional teams to drive product quality and quality system improvement projects.
• Attend to customer enquiries and provide timely and accurate response.
• Plan and conduct internal audits and supplier audits. Follow up on audit findings.
• Visit customers acting as West representative.
• Prepare reports to highlight QA monthly and quarterly statistics.
• Support Senior QA Manager to maintain the ISO 15378 / 9001 system
• Any other duties as assigned by Senior QA Manager.
Education and Experience:
• Bachelor’s degree in BioTech / Chemical Engineering / Process Engineering / Mechanical Engineering / Life Science
• At least 10 years of experience in quality assurance in a Pharmaceutical or Medical Devices manufacturing environment
• At least 3-5 years of people management experience
• Certified Quality Auditor and Six Sigma Green Belt preferred
Knowledge, Skills and Abilities:
• Working knowledge of ISO 15378 and ISO 9001 or equivalent quality standards
• Good knowledge of cGMP requirement and strong quality mindset
• Effective communication and interpersonal skills
• Ability to interact with customers at all levels
• Strong leadership qualities and ability to manage multiple priorities
• Ability to make independent and difficult decisions
• Proactive, strong-minded, quick thinker and assertive
• Good project management skills
• 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 Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all timesHighlight 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