Assistant Manager Quality Assurance

DKSH; Shah Alam; On-site; MYR 60,000 - 80,000; Full time

Job summary

A healthcare company in Shah Alam seeks a Quality Assurance professional to manage compliance and audits. The role involves overseeing deviation reports, conducting audits, and maintaining quality documentation. Ideal candidates have a Bachelor's degree in Pharmacy, are registered Pharmacists, and possess at least five years of relevant experience, along with certifications in Quality Auditor and Six Sigma. Applicants must demonstrate proficiency in quality assurance methodologies and office tools, and fluency in English is essential.

Qualifications

• Demonstrate knowledge in Quality Assurance tools, concepts and methodologies.
• Proven experience in GMP manufacturing.
• Demonstrate fluency in English, both written and spoken.

Responsibilities

• Initiate, track, follow up, and close internal and external deviation reports.
• Manage client/internal audits and prepare audit reports.
• Conduct QA walkthroughs and perform trend analysis.

Skills

Quality Assurance tools knowledge

Regulatory requirements knowledge

GMP/ISO9000 knowledge

Experience in GMP manufacturing

Office productivity tools proficiency

Fluency in English

Education

Bachelor's Degree in Pharmacy

Registered Pharmacist certification

Quality Auditor/Engineer certification

Six Sigma certification

Job description

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

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.

Qualifications

• 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

• Possess Bachelor's Degree in Pharmacy, and must be registered 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

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.