Assistant Manager Quality Assurance
DKSH Scientific Solutions
Date: 5 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
Job Function: Client and Customer Services
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.
- 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.
- 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.
- Maintain independence by avoiding conflicts of interest between quality/regulatory responsibilities and day-to-day operational activities.
- Supervise the discharge and handling of psychotropic drugs in compliance with regulations.
- 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 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
Job Function: Client and Customer Services
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