Assistant Manager Quality Assurance
DKSH
Date: 1 day ago
City: Shah Alam
Contract type: Full time
Job Summary
Assist in all quality assurance related matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare.
General Responsibilities
Quality Compliance
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
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