Quality Assurance Manager (Health)

JOB SUMMARY

This position will report to the Factory Manager (GM) and is responsible for overall QA activities, ensure that all products meet the specified applicable standard, plan, direct, and coordinate overall quality assurance/control requirement during designing, procurement, production, and delivery stage to the customers.

PRIMARY RESPONSIBILITIES

• Able to develop Quality Management System in the company to fulfill the requirements and get certifications in accordance with government regulations
• Plan, direct, and coordinate overall quality assurance/control requirement during designing, procurement, production, and delivery stage to the customers.
• Ensure that all products meet the specified applicable standard by review all production records and ensure that production process meets the specified applicable standard.
• Establish and ensure that GMP and quality Management System are applied within the organization.
• Plan, conduct, and monitor audit activities in organization.
• Plan, conduct, and monitor calibration, validation, and stability in organization.
• Cooperate with quality system auditor company/authority to conduct third party audit in organization
• Maintain high level of employee morale competence, development, training, and conduct annual appraisal to all subordinates.
• Cooperate with internal and external parties such as suppliers, managers and so on to prevent any probable delay.
• Report all performances of the department periodically.
• Ensure the cleanliness in QC Department area and everybody in the department maintains safety and ethical standards.
• Working with managers effectively to execute the policies and goals of the organization.

• Bachelor degree of minimum requirement majoring in pharmacy (pharmachist).
• Honest, empathic, assertiveness in socializing/ communicating and have a illingness to improve and cooperate.
• Neat and detail.
• Experienced in same field for 5 years of minimum.
• Experienced and have knowledge in medical device or pharmaceutical industry.
• Have knowledge about Quality Management System, ISO 13485, and GMP.
• Able to operate computer, especially OpenOffice and Microsoft Office.
• Have good knowledge in process production/operation statistic.
• Have knowledge in occupational health and safety standard.
• Have good knowledge in production and methodology.
• Fluent in English (active and passive).
• Will be placed at Kawasan Industri Sentul Bogor