Commercial Quality Executive

2 weeks ago


Selangor, Malaysia Johnson & Johnson Family of Companies Full time

Johnson & Johnson (J&J) is a provider of consumer, pharmaceutical and medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease and improve the quality of life of patients and consumers.
This role reports solid line to the Commercial Quality Associate Manager in Malaysia.
This role is responsible to support the execution of quality and compliance activities for the Pharmaceutical segment. This role is also responsible to oversee the cross-segment QMS maintenance activities such as non-conformances and CAPA, change control and complaint management.

**Key Responsibilities**
- Manages the processing of Medical Device and Pharmaceutical product complaints for the site in a timely manner and monitor related trends.
- This role also serves as the SME for the change control and Non-conformance and CAPA management in ETS Trackwise system.
- This role also coordinates the key quality metrics reporting on a monthly basis. This includes, Non-conformances, CAPA, change control, (cross segment), Complaints, and Audit Actions tracking and monitoring as per timelines.
- Supports the activities related to the execution of Pharmaceutical recall according to internal procedures and local regulation.
- Provides support in the execution of repack/relabel activities including the creation of repack/relabel work instruction for Pharmaceutical products to ensure compliance with local regulations and internal procedures.

Supports the following operational activities related to Pharmaceutical segment with cross functional stakeholders:

- New Product introduction
- Product Change management
- Product discontinuation
- Change control
- Non-conformances and CAPA
- Product inspection and release
- Temperature excursion
- Trade return disposition

Supports activities related to Supplier/Distributor lifecycle management (qualification, audits and disengagement).

Supports internal and external audits for Johnson and Johnson Malaysia, including Brunei market. Ensures compliance to local regulations and J&J quality policies, standards and procedures.

Support projects and duties as assigned by manager.

**Qualifications**
- Bachelor’s degree or equivalent in Science, Biology, or related discipline.
- Minimum 2 years of experience as a quality assurance personnel or related role.
- Proficiency in written and spoken English.
- Requires knowledge and understanding of industry and regulatory standards and overall quality management system (QMS).
- Good interpersonal and communication skills that fosters partnership, and influences diverse stakeholders.
- Proficiency in common softwares such as Excel, Word, Powerpoint. Ability to learn and master the various systems used manage activities and data related to Johnson and Johnson QMS.
- Agile and able to work independently and achieve objectives related to assigned responsibilities.

**Primary Location**
Malaysia-Selangor
- **Organization**
Johnson & Johnson Sdn. Bhd. (8275)
**Job Function**
Quality
**Requisition ID**
2206010989W


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