Johnson & Johnson
Commercial Quality Specialist
Commercial Quality Specialist
1 year contract with high potential to renew
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining our client Johnson & Johnson
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Johnson & Johnson WORKSENSETM (via Randstad Sourceright) is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.
As an equal opportunity employer Johnson & Johnson value diversity at their company. They don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
This role is responsible to support the Medical Device and Pharmaceutical sectors on the execution of Quality activities related to the registration, import, supply, distribution, and post-market surveillance of products in the Singapore market. The role is also responsible to support the timely management and execution of non-conformances, CAPAs, change controls, document and training, supplier management and key metrics monitoring related to these areas. Lastly, this role will also involve audit readiness support and preparation.
- Quality & Compliance Responsibilities
- Support the product quality complaints and adverse event handling process for the site.
- Support the execution of activities related to Stop Shipment, Quality Holds, Field Notifications and Field Actions
- Support the creation and execution of NCs/CAPAs and Change Controls
- Monitor and report for timely completion of Quality records, including NCs/CAPAs and Change Controls
- Support training plan administration process and document management system
- Support key quality metrics monitoring and reporting, including Non-Conformances, CAPAs, Complaints, Change Control and Audit Actions
- Support internal and external audit plan, conduct audit to distributors, co-packers, 3rd party service providers, materials and POLO suppliers
- Commercial Support
- Support the review of incoming product inspections and temperature data monitoring
- Support activities related to quality system compliance and the management of distributor and co-packer activities
- Audit Readiness
- Provide support to ensure compliance and audit-readiness to J&J Quality Policy Standards and applicable procedures.
- Provide support to execute requirements regarding lifecycle management of GxP documents and records to ensure regulatory compliance and business continuity.
- Understand and ensure continued compliance to global and local regulatory requirements with respect to assigned responsibilities.
- Bachelor's degree or equivalent in Science, Data Science, Pharmacy or related discipline
- 1 to 2 years of Commercial Quality experience in the medical device or pharmaceutical industry
- Basic knowledge and understanding of Good Manufacturing Practice and Good Distribution Practice standards, as well as the key elements of a quality organization
- Proficiency with Microsoft applications such as Excel, Word, Powerpoint
- Proficiency with Data Analytics and tools
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
EA License: 94C3609
Reg No: R22104540