Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities

• Assist with the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the H.S.A GDP Guidelines.
• Provide support for investigation into non-conformances and customer complaints.
• Maintenance and Follow-up on Corrective Actions and Preventive Actions (CAPAs).
• Provide the trainings and coordinate the trainings for the staff.
• Registration of the trainings into the electronic Quality Management System (eQMS) and running of reports.
• Assist with the documentation review after an operational activity.
• Collection of Temperature Data and Monitoring of the temperature environmental conditions.
• Reporting of day-to-day activities.
• Take care of and communicate with internal and external contacts.
• Control administrational aspects of the facility (e.g. archiving).
• Promote a “quality” culture within the company.
• Performing physical checks for GMP and GDP related processes

Job Requirements

• Possess at least a Diploma in Pharmacy, Life Sciences or relevant fields.
• Possess at least 2 years of pharmaceutical science work experience (or prior Life Science internship experience) is preferable .
• Experience with ISO 13485 standards is an advantage.
• Knowledge of GMP and/ or GDP guidelines is an advantage.
• Able to work in a fast-paced environment
• Work well independently/with minimal supervision and with others in a team
• Proficient in Microsoft Office especially Excel
• Candidate needs to be based in Singapore.