Lowongan Quality Assurance Manager di PT Gelflex Indonesia

Responsibilities will cover:

• All Quality Management activities to ensure compliance with ISO, GMP, CE, US-FDA, and all applicable quality system requirements.
• Being the Management Representative for the Indonesian company, ensuring the quality management system is operated and managed effectively and in line with all regulatory requirements. 
• Promote awareness of regulatory requirements and quality management system requirements throughout the business.
• Management of change control, risk and all related quality functions.
• Taking an active leadership role of the QA team.

Skills Required:

• Fluent in both written and spoken English.
• Degree qualified in a science or engineering discipline (Preference for candidates with backgrounds in Chemical Science, Chemical Engineering, Pharmacy, or equivalent)
• A minimum of 7 years' of progressively responsible experience in Quality Assurance, Quality Control or related roles. (Preference for candidates with experience in Medical Devices Manufacturing).
• Strong understanding of quality management principles, methodologies and standards, including ISO, CE and FDA. Knowledgeable about current Good Manufacturing Practice
• The ability to identify root causes of quality issues and develop effective corrective and preventive actions (CAPAs). Experience with methodologies like root cause analysis and failure mode and effects analysis (FMEA).
• Strong interpersonal skills demonstrated data analysis expertise, and effective communication abilities.
• Experience of leading and managing QA teams, including managing personnel, and overseeing QA processes. Experience with talent development, performance reviews and mentoring is important, as well as being capable of motivating, and developing team members at various levels.
• Meticulous attention to detail and the ability to identify even minor quality issues or deviations.
• Ability to interpret data, trends, and metrics related to quality performance, and to make informed decisions based on that analysis.
• Proficiency in project management methodologies to effectively plan, execute, and monitor QA projects, ensuring they stay on schedule and meet quality standards.