Job Number: 4644

External Description:

 

Business Quality Specialist 

Our client is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly  a billion  people  every  day.  Our Family  of  Companies throughout the world compete  in consumer, pharmaceutical  and medical  devices  & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Role Description

This role is responsible to support the execution of Quality activities related to incoming inspection for
Pharmaceuticals sector and review the complaint and adverse event records for Medical Devices sector.
This role also supports the Non-Conformances, CAPAs, Change Controls and Work Instructions, especially on temperature excursion and repack/relabel for Pharmaceuticals and Medical Devices sector. In addition, this role supports the site audit readiness in training administration and document
management.

Responsibilities

1. Sales & Marketing Support (Pharm)

• Support the review of incoming inspections and temperature data monitoring for Pharm products
• Support the creation and investigation of NCs/CAPAs and monitors the trend and complete the investigation timely for the NCs/CAPAs related to temperature excursion

       2. Sales & Marketing Support (Medical Devices)

• Support in the creation of Work Instructions for repack/relabel for Medical Device products.
• Support the review and closure of complaint and adverse event records from CRM system

      3. Audit Readiness

• Support training administration process for LOC
• Support document management quality system for LOC
• Ensure compliance and audit-readiness to J&J Quality Policy Standards and applicable procedures.

      4. Support the Singapore local operating company in tracking and monitoring of           Non- Conformances, CAPAs, Change Controls and Audit Actions as per timelines         for Consumer, Medical Devices and Pharmaceutical sectors.

       5. Coordinates key quality metrics reporting. This includes Non-Conformances, CAPAs, Complaints, Change Control and Audit Actions tracking and monitoring as per timelines.

        6. Understand and ensure continued compliance to global and local regulatory requirements with respect to assigned responsibilities.

Job Requirements

1. Bachelor's degree or equivalent in Science, Pharmacy or related discipline

2. Familiarity with current Good Manufacturing Practice, the regulatory systems and product registration requirements in Singapore.

3. Excellent verbal and written communication skills - proficiency in written and oral English is required.

4. Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.

5. Proactive team player, able to take charge and follow-through.

6. Proficiency with Microsoft applications such as Excel, Word, Powerpoint.

Job Number: 4644

Community / Marketing Title: Business Quality Specialist

Location_formattedLocationLong: Science Park, South West SG