Associate QMS Engineer

JOB SUMMARY
This position will be responsible for following Quality Management System included document and change management; review, control and manage batch record also release the product batch in accordance with regulatory requirements; Learning Management System (LMS) administration
ESSENTIAL DUTIES
General
• Support activites related to internal and external audit
• Manage Quality Management System and supporting improvement projects
• Arrange task and main-power to get targets
• Provide training to new and junior members
Detail
Document and change management
• Reviewing and releasing all documents to define product configuration and control manufacturing processes.
• Training Document and Change Management and support to team members as well as new associates for their development
• Responsible for BOM/BOR Management in SAP for material specifications and QMS documents in Vietnam
Production control
• Being responsible to verify batch record follow manufacturing procedures and specification to make sure that it satisfies all quality and regulatory requirement.
• Being responsible to get approval of COC Release the batch.
• Being responsible for appropriate storage management of records, etc.
Training
• Defining and training for determined roles, on-boarding and develop trainings.
• Performing LMS administration included but not limited on managing and optimizing the item, training assignment, curricula, report in LMS system
• Working with functional team on optimizing training process and relevant activities
OTHER DUTIES AND RESPONSIBILITIES
• Other duties as assigned by superior.

• Preferred for having wide-range knowledge including quality, regulation and team management
• Preferred the knowledge acquired by experiences in production field and/or laboratory control.
• SuccessFactors/Plateau LMS administration experience is a plus.
• At least 02 years experiences
Skills
• Problem solving
• Self-directed individual with strong motivation and willingness to take initiative.
• Preferred for education/training of GMP, GLP, ISO 13485, validation, safety, pharmaceutical requirements and manufacturing control.
• Independent and team working effectively.
• Use MS office effectively.
• Communication skills.
• Ability of judging and advising to improvement action objectively based on knowledge of manufacturing facilities, required quality, and production technology.
• Good verbal and written communication ability in English.

Premium Healthcare

Laptop

Cellphone provided

Cập nhật gần nhất lúc: 2022-11-05 15:12:05