Assistant Manager Quality Assurance

DKSH Scientific Solutions


Date: 16 hours ago
City: Shah Alam
Contract type: Full time
Title: Assistant Manager Quality Assurance

Location:

Shah Alam, MY, MY

Global Business Unit: HEC

Job Function: Client and Customer Services

Requisition Number: 194282

Description

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

Requisition Number: 194282

Job Function: Client and Customer Services

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