Quality Technician Validation & Qualification

GOODSCIENCE SDN. BHD.; Kedah; Presencial; MYR 36.000 - 60.000; Jornada completa

Descripción de la vacante

GOODSCIENCE SDN. BHD. is hiring a Quality Technician for Validation & Qualification to support calibration and qualification activities in a GMP environment.

Diploma or Degree in Science, Engineering, Pharmaceutical Technology, Biotechnology, Chemistry, Instrumentation or related field is required; fresh graduates may be considered. Responsibilities include maintaining the Calibration Master List, coordinating calibration activities, reviewing certificates, and ensuring no overdue calibrations.

Formación

• Diploma/degree in science or engineering or related field.
• Fresh graduates may be considered.
• Experience in pharmaceutical, medical device, GMP or regulated manufacturing environment is advantageous.

Responsabilidades

• Maintain Calibration Master List for production, lab, utility and other equipment.
• Coordinate calibration activities and monitor due dates.
• Review calibration certificates and ensure acceptance criteria are met.

Conocimientos

Calibration knowledge

Validation principles

GMP environment

Educación

Diploma/Degree in Science, Engineering, Pharmaceutical Technology, Biotechnology, Chemistry, Instrumentation or related field

Descripción del empleo

Quality Technician Validation & Qualification

Diploma / Degree in Science, Engineering, Pharmaceutical Technology, Biotechnology, Chemistry, Instrumentation or related field.

Fresh graduates may be considered.

Experience in pharmaceutical, medical device, GMP or regulated manufacturing environment will be an advantage.

Basic knowledge of calibration, equipment qualification and validation principles.

Calibration Management

Maintain and update the Calibration Master List for production, laboratory, utility and other measuring equipment.

Coordinate internal and external calibration activities according to the approved calibration schedule.

Monitor calibration due dates and ensure no overdue calibration.

Review calibration certificates and verify that results meet specified acceptance criteria.

Ensure calibrated equipment is properly identified with calibration status labels.

Follow up on equipment that fails calibration and coordinate the necessary investigation, adjustment, repair or replacement.

Maintain proper calibration records and supporting documentation for traceability.

Support preparation and monitoring of calibration KPIs and overdue reports.

Validation Activities

Support validation activities including:

Equipment Qualification (DQ/IQ/OQ/PQ)

Process Validation

Cleaning Validation

Computerized System Validation (where applicable)

Temperature Mapping

Utility/System Qualification

Hanan Medicare group is a privately owned Bumiputera pharmaceutical group of companies established to be a medical goods and services provider for both the public and private sectors. Leading Hanan Medicare group is Dr Mohammad Sharif bin Abu Hassan, an experienced doctor with more than 30 years of practice in medicine with the Ministry of Health and later his own clinic, Klinik Hanan since 2015.

The main company, Hanan Medicare Sdn. Bhd. incorporates pharmaceutical trading as well as our primary care health service, Klinik Hanan. The trading division currently focuses on the supply of disposable products and hospital sundries on a tender or quotation basis. Our quest is to provide exemplary standards of service and quality in the healthcare products supply industry with plans for expansion into the supply of medical devices. With deep knowledge and experience in the medical field, we strive to provide the community with quality healthcare products at affordable prices. This goal is reflected through our GP Clinic and health facility, Klinik Hanan which is dedicated to the care of outpatients with cost-effective, highquality health care in a modern setting.

In 2021, Hanan Medicare Sdn. Bhd. acquired GoodScience Sdn. Bhd., a long-standing pharmaceutical manufacturing company based in Kundang, Selangor. As the production and R&D subsidiary, GoodScience strives to identify and develop quality generic products that are accessible and affordable. It focuses on the manufacturing of ethical and over-the-counter (OTC) drugs in the form of tablets and soft capsules.

Major Business Segments:

• Primary and Secondary Packaging

Hanan Medicare group is a privately owned Bumiputera pharmaceutical group of companies established to be a medical goods and services provider for both the public and private sectors. Leading Hanan Medicare group is Dr Mohammad Sharif bin Abu Hassan, an experienced doctor with more than 30 years of practice in medicine with the Ministry of Health and later his own clinic, Klinik Hanan since 2015.

The main company, Hanan Medicare Sdn. Bhd. incorporates pharmaceutical trading as well as our primary care health service, Klinik Hanan. The trading division currently focuses on the supply of disposable products and hospital sundries on a tender or quotation basis. Our quest is to provide exemplary standards of service and quality in the healthcare products supply industry with plans for expansion into the supply of medical devices. With deep knowledge and experience in the medical field, we strive to provide the community with quality healthcare products at affordable prices. This goal is reflected through our GP Clinic and health facility, Klinik Hanan which is dedicated to the care of outpatients with cost-effective, highquality health care in a modern setting.

In 2021, Hanan Medicare Sdn. Bhd. acquired GoodScience Sdn. Bhd., a long-standing pharmaceutical manufacturing company based in Kundang, Selangor. As the production and R&D subsidiary, GoodScience strives to identify and develop quality generic products that are accessible and affordable. It focuses on the manufacturing of ethical and over-the-counter (OTC) drugs in the form of tablets and soft capsules.

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