QA Specialist

Description

• Adverse event and/or Health Authority reporting

Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure

• Change Control

Lead site change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken. Monitors related metrics and initiates actions for improvement.

• Complaints management

Lead the end-to-end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends, related metrics and initiates actions for improvement.

• Document control

Support and ensure site compliance to document lifecycle management.

• Labeling and packaging

Provides Quality support (such as updating quality agreements, issuing redressing instructions) in repack/relabel operation to ensure compliance to internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.

Qualifications

At least BSc. in Science or Engineer or Pharmacy or equivalent from a reputable university preferably with excellence academic background

Professional Experience At least 1 year professional experience or leading in the field of Quality Assurance, Business Quality or related functions

Experience of quality audit

Excellent interpersonal, leadership and quality management skill exposure to quality standard e.g. ISO, GMP, GDP, RA requirements will be desirable

Experience of exposure to Regional communication

Capability to communicate and good coordination and interpersonal skills

Good command of written and spoken English and Bahasa Indonesia together with computer literacy