Job Summary

Assist in all quality assurance related matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare.

General Responsibilities

Quality Compliance

• Initiate, track, follow up, and close internal and external deviation reports, including performing trend analysis on all reported deviations.
• Responsible for managing client/internal audits, including audit reports and deviation reports.
• Serve as a backup for monitoring change control records, ensuring all changes are thoroughly evaluated, documented, and recorded.
• Coordinate and conduct QA walkthroughs, prepare walkthrough reports, and perform trend analysis when necessary.
• Support the preparation and maintenance of quality-related documents (e.g., Quality Agreements).
• Contribute to and follow up on assigned continuous improvement projects and programs.
• Participate in and follow up on all GxP-related activities.
• Plan, schedule, and execute vendor evaluation and qualification audits.
• Promptly report any detected non-conformities to the Quality Assurance Pharmacist.
• Manage CAPA processes by issuing tickets to process owners and maintaining CAPA tool user and ticket records.
• Prepare and submit monthly reports on regional and country quality KPIs.
• Participate in annual risk assessments and maintain the risk register.
• Support and follow up on bi-annual Management Review Meetings.

Post-Market Activities

• Support for product quality complaints by reporting internal or external quality issues/defects to clients within stipulated timelines.
• Support to provide monthly product quality complaint logs to the RA Pharmacist for DKSH PV log updates and periodic reconciliations with clients.
• Ensure all client and customer quality complaints are properly investigated and resolved.

Management Reporting

• Identify and report risks related to products, processes, and systems to management.
• Communicate outcomes of regulatory inspections, ensuring responses are complete and close to verification.

Independence

• Maintain independence by avoiding conflicts of interest between quality/regulatory responsibilities and day-to-day operational activities.

Registered Pharmacist Responsibilities

• Supervise the discharge and handling of psychotropic drugs in compliance with regulations.

Functional Skills and Knowledge

• Demonstrate knowledge in Quality Assurance tools, concepts and methodologies
• Demonstrate knowledge of relevant regulatory requirements
• Demonstrate knowledge in GMP/ISO9000 or other quality management systems
• Proven experience in GMP manufacturing
• Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
• Demonstrate fluency in English, both written and spoken

Education

• Possess Bachelor's Degree in Pharmacy, and must be regsitered Pharmacist.
• Certification in Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be an advantage
• Minimum five years’ experience in a similar role
• Minimum three years’ experience in a managerial capacity