Job Summary and Key Objectives
The job functions cover:
a. Develop and control the product quality to meet customer requirements.
b. Develop and control the manufacturing process to meet the legal requirements.
c. Develop and control contamination management processes to ensure high cleanliness of molecular products and acceptable air quality in production environments.
This role needs a robust strategy to support Camfil APAC's business growth plans. Need to understand customer detail requirements and develop effective quality control processes.
Key Responsibilities include:
a) Quality Assurance and Product Reliability
- Maintaining a strong consumer sensibility while leading or participating in customer journey mapping or other user experience quality sessions
- Represent Quality on the MCC Product implementation and the New MCC Process implementation
- Appraise customers requirements and make sure they are satisfied
- To ensure that product specifications required by the customers are strictly adhered.
- To be responsible for the preparation of quality inspection, test procedures and relevant in-house specifications.
- Work with both Operations and R&D teams to ensure and monitor the stability of all MCC raw materials and products
- Ensuring proper raw material inspection and monitoring the quality of the raw material from suppliers and harmonising among plants.
- To be responsible for determining and reporting the principal causes of quality losses and non-conformance.
- To standardize incoming, in-process and final quality activities among the plants.
- Carrying out a vendor audit if necessary.
- Harmonize the In-process inspection among plants (based on audit).
- Standardize final quality inspection to ensure items delivered to the customer meet the specifications requirement (based on audit).
- Monitor all operations that affect the quality of MCC products.
- Preparing specifications for new products, new test methods and updating relevant documents based on improvements related to quality.
- Facilitate proactive solutions by collecting and analysing quality data
- Assure Quality milestones and Quality stage gate deliverables are achieved
- Stay up-to-date with industry trends and best practices related to quality control, sharing knowledge and insights with team members and stakeholders.
Contamination Control
- Standardizing AMC/VOC practices across multiple plants (best practice sharing)
- Develop and implement AMC/VOC monitoring and control strategies across regional plants
- Assist management on contamination control matters and ensure compliance with regulatory requirements.
- Determine SOPs and specifications for acceptable air quality in production environments.
- Respond to contamination issues, conduct investigations, and propose improvement/mitigation plans.
- Monitor and report contamination control performance, propose improvement projects, and develop air monitoring plans.
- Ensure real-time monitoring systems are operating properly.
- Support product design, development, and manufacturing from a contamination control perspective.
- On-site support at the customer's application level within the region to assist & support the sales team in technical matters related to outgassing.
- Collaborate and work closely with Lab Chemist/personnel on outgassing data, analysis and any new test capability enabling.
- Design and execute experiments to qualify raw materials in relation to contamination control.
- Act as a champion of contamination control across QA, PPD, production, facilities, and supporting teams.
- Support Product Managers and the global MCC Team when required.
Requirements:
- Bachelor's degree in chemistry, quality or in a relevant field
- Required level of experience is 5 years or more
- Have experience of working in or knowledge of Quality Assurance
- Preferably with prior experience from the manufacturing or industrial industry.
- Have experience working in a GMP-regulated environment
- Excellent knowledge of quality control principles.
- Excellent knowledge of software QA tools and processes
- Solid understanding of quality control procedures and relevant legal standards.
- High level of integrity, ability to handle sensitive and confidential information with discretion.
- A sense of ownership and pride in your performance and its impact on the company's success
- A keen eye for detail and a results-driven work approach
- Critical thinker, strong organisational and problem-solving skills.
- Excellent project management skills.
- Excellent time management skills
- Competence to build and effectively manage communication and interpersonal relationships at all levels of the company
