- Glenmarie, Selangor
- Pharmaceuticals & Medical Devices (Healthcare & Medical)
- Full time
- RM 3,000 – RM 4,500 per month
Job Purpose
- Ensure that all quality-related matters and overall GMP activities conform to PIC/S standards, relevant QMS requirements, and Duopharma HAPI Sdn. Bhd.’s internal policies to consistently deliver high-quality products.
- Monitor, evaluate, and assess all production and quality control activities and documentation to ensure compliance with GMP, Quality Systems, and company standards.
Key Accountabilities
- Conduct in-process checks on production operations, environmental monitoring, and related facilities to maintain GMP compliance and product quality.
- Review and ensure all SOPs, quality documents, validation protocols/reports, and Site Master File are current, traceable, and compliant with regulatory requirements.
- Act as a qualified trainer for onboarding and certifying new IPQA personnel via structured training programs.
- Lead and report on NDMA and NDSRI projects, ensuring proper controls and documentation to maintain product quality assurance.
- Manage and monitor traded cold chain product reviews and release, ensuring timely disposition with market compliance.
- Escalate major non-conformities and product quality issues to QA Management and Production HOD for immediate resolution.
- Make real-time decisions on quality issues, including stopping production and freezing stock when necessary to protect product integrity.
- Review and verify all batch records, COAs, and manufacturing documents for accuracy and compliance prior to batch release.
- Recommend and support quality system improvements and process enhancements to address internal or supplier-related quality issues.
- Compile and assess documentation for complaints, deviations, non-conformances, and coordinate effective CAPA implementation and closure.
- Serve as the QA Person-in-Charge (PIC) for Production Change Control, tracking and ensuring timely completion of all change activities.
- Oversee the rejection process for materials, ensuring appropriate documentation, procedure compliance, and disposal.
- Review all packaging artwork to ensure alignment with GMP and product registration requirements.
- Review and manage Material Management Forms and execute material codes in SAP (MRP Module), including master data monitoring.
- Participate in new source evaluations to assess material suitability for existing product lines.
- Handle finance-related transactions (PR, PO, MIGO) for EU-related expenses, including budget tracking and payment monitoring.
- Perform any other tasks as assigned by management.
Person Specifications
Qualifications
- Bachelor’s Degree in a related field: Pharmaceutical Sciences, Pharmacy, Chemistry, Biology, Pharmaceutical Technology, Medicine, or Veterinary Medicine.
Experience
- Minimum of 2–3 years of working experience, preferably in a GMP-regulated environment.
Technical Competencies
- Strong understanding of GMP and Quality Systems
- Familiarity with SAP (MRP Module) preferred
- Proficient in Microsoft Office (Word, Excel, PowerPoint)
Behavioral Competencies
- Logical and detail-oriented thinker
- Strong compliance mindset and objective evaluation
- Independent, well-organized, and good in time management
APPLY AT :- JOBSTREET MALAYSIA – DUOPHARMA BIOTECH BHD GROUP