Assistant Manager Quality Assurance

DKSH Group; Shah Alam; On-site; MYR 90,000 - 120,000; Full time

Job summary

A leading healthcare company seeks an Assistant Manager Quality Assurance in Shah Alam. This role involves managing quality assurance processes, conducting audits, and ensuring compliance with regulatory requirements. The ideal candidate holds a Bachelor's degree in Pharmacy, is a registered Pharmacist, and has at least five years of experience in quality assurance, with a minimum of three years in a managerial role. Proficiencies in GMP and relevant quality management systems are essential. This position offers opportunities for continuous improvement and involvement in quality-related projects.

Qualifications

• Minimum five years’ experience in a similar role.
• Minimum three years’ experience in a managerial capacity.

Responsibilities

• Manage quality assurance deviation reports and audits.
• Conduct QA walkthroughs and prepare reports.
• Report product quality complaints and ensure investigation.
• Perform monthly reporting on quality KPIs.

Skills

Knowledge in Quality Assurance tools

Knowledge of regulatory requirements

Knowledge in GMP/ISO9000

Experience in GMP manufacturing

Proficiency in Excel, Word, PowerPoint

Fluency in English

Education

Bachelor's Degree in Pharmacy

Certification in Quality Auditor / Quality Engineer / Quality Improvement Associate / Six Sigma

Job description

Title: Assistant Manager Quality Assurance

Location: Shah Alam, MY, MY

Global Business Unit: HEC

Job Function: Client and Customer Services

Requisition Number: 194282

Job Summary

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

General Responsibilities

• 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 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.