Quality Systems Lead – External Quality & Complaints

APOTEX; Hinoba-an; On-site; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Disability accommodation

Job summary

APOTEX, a Canadian-based global health company, seeks a QA/QC professional to manage third-party customer complaints and ensure regulatory compliance across the supply chain. The role supports in ensuring product quality and aligns with global GMP standards.

You will coordinate with Regulatory Affairs, Corporate Quality, and external manufacturers to ensure timely CAPA, documentation control, and continuous improvement across External Quality functions.

Qualifications

• Bachelor’s degree in science or college diploma in pharmaceutical technology.
• Strong knowledge of global cGMPs (HC, FDA and EU).
• Experience with QA/QC systems for human drug products.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Handle customer complaints for products manufactured by third parties.
• Triaging and logging incoming complaints and sending acknowledgement letters.
• Notify third-party manufacturer of complaints and track investigation progress.
• Review investigation reports to ensure CAPA adequacy and close complaints with response letters.
• Assist in developing processes for Product Compliance File assessment and gap closure.
• Coordinate SOP development and a centralized documentation control system for External Quality.

Skills

Global cGMP knowledge

Detail-oriented

Multitasking

Analytical thinking

Inter-personal communication

Independent worker

Team collaboration

Stakeholder management

Education

Bachelor’s degree in science/College Diploma in Pharmaceutical Technology

Tools

SAP

TrackWise

Job description

APOTEX, a Canadian-based global health company, seeks a QA/QC professional to manage third-party customer complaints and ensure regulatory compliance across the supply chain. The role supports in ensuring product quality and aligns with global GMP standards.

You will coordinate with Regulatory Affairs, Corporate Quality, and external manufacturers to ensure timely CAPA, documentation control, and continuous improvement across External Quality functions.