QA (Quality Assurance) Manager [ GMP, GDP, ISO, KKLIU, HALAL]

Position: QA Manager

Industry: Herbal Medicine Supplier

Location: Diamond Valley, Bayan Lepas, Penang

• Job Responsibilities:

Lead the Quality Assurance Team to access the product problems and solutions

• Evaluate adequacy of quality assurance standards, ensure ongoing compliance with quality and industry regulatory requirements.

Responsible in lead team QA and QC personnel in accordance of regulatory requirements in every manufacturing process (Incoming Inspection, In Process and Finish Good).

• Lead and coordinate the Internal Audit and external audits conducted by Authorities (GMP, ISO, HALAL, KPDN, BKKM, JKKP, KASTAM)

Upgrade procedures & standards for documents management.

• Manage all the controlled documents (eg. GMP, GDP, ISO, KKLIU, HALAL, SPECIFICATION SHEET and similar or related documents, current and future) from creation to archive.

Issue controlled documents such as BMR, SOP, KKLIU, forms, Lab test, etc as requested by other departments.

• Assist with administration for all controlled documents (ie. GMP, GDP, ISO, KKLIU, HALAL, SPECIFICATION SHEET and similar or related documents, current and future).

Perform the registration of product with NPRA, HALAL application, BKKM registration, KPDN registration and KASTAM.

• Perform registration of product for overseas market with Malaysia Customs, Singapore HSA/SFA and Brunei Pharmaceutical Services.

Upgrade & implement training procedures and training management system.

• Support for all issues relating to controlled documents (ie. GMP, GDP, ISO, KKLIU, HALAL, SPECIFICATION and similar or related documents, current and future).

Review the records in the archive cabinets for easy traceability.

• Evaluate adequacy of quality assurance standards, ensure ongoing compliance with quality and industry regulatory requirements.

Interpret and implement latest quality assurance standards and procedures by Industry regulations such as GMP, GDP, HALAL, KKLIU, ISO, Overseas Markets and other future regulations.

• Create QA department quality assurance policies and procedures.

Investigate non-conformance issues. Develop, recommend and monitor corrective and preventive actions.

• Review, checked and approved the product artworks from Marketing Department and Supplier.

Establish the Filling system.

• Perform and review with Equipment Preventive Maintenance, Calibration and Scheduling.

Support the Staffs Medical Checking and Scheduling.

• Support Pest Control Visiting and Scheduling.

Involve in annual budget exercise, variance analysis for previous years, preparation of yearly department budget, setting of departmental OKR and setting of KPI

• Create, implement and monitor risk management activities.

Undertake ad-hoc project that may be assigned (from time to time) to improve document control, QA management and operation efficiencies (e,g: cost optimisation, process and record digitalization, and other related activities.)

• Create and maintain KPI dashboards/ Process Completion Status dashboards as needed to communicate status to the HODs & Business Units as a whole

• Requirements:

Malay male

• At least 5 years of experience

Well-versed with ISO 9001 : 2015

• Demonstrates leadership ability with a strong strategic mindset

Able to plan and execute change according to company direction

Job Type: Full-time

Pay: RM6,

• 00 - RM7,000.00 per month
  
  Schedule:
• Day shift

Application Question(s):

• How well-versed are you with ISO 9001 : 2015

How long is your notice period

• How much is your expected salary based on the salary range stated

Experience:

• Quality assurance: 5 years (Required)

QA/QC: 5 years (Required)