Specialist, Quality Systems

**THE OPPORTUNITY**
- ** Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide**:

- ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **top-ranked biopharmaceutical company on the Straits Times **and** Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).**:

- Join the** premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**Job Purpose**

Responsible for the management and maintenance of Supplier Transparency (ST) system database for supplier, material, and supply chain information enabling:

- accurate representation of the supplier-material record for each company product manufactured at Singapore site thereby resulting in continued compliance with Good Manufacturing Practices regulations for the pharmaceutical industry
- correct supplier audit assessment by the company Global Compliance and Auditing group; and thereby allowing notification of using sites in the event of audit observational findings, supplier changes or compliance discrepancies submitted by the supplier
- Represent Singapore site as main Point-of-Contact (POC) and Subject-Matter-Expert (SME) for Supplier Transparency (ST) to:

- Liaise with global Supplier Quality Management (SQM) team and implement global ST programs and initiatives at the Singapore site level;
- Escalate Singapore site issues regarding ST back to the SQM team and thereby drive timely resolution of issues at the Singapore site.
- Lead efforts and collaborate with key Singapore site stakeholders (e.g. Quality, Global Procurement, Pharm Tech Operations, Lab, Integrated Process Team Operations, etc.) to ensure that Singapore site ST data complies with global ST SOP; is supportive of the requirements for supplier audits /regulatory inspections (where applicable); and is aligned with local purchasing system.

**Main Responsibilities**:
**ST System Database Maintenance**
- Ensure the company site approved supplier list in ST is current and maintained in alignment with local purchasing system by performing routine data maintenance which includes, but not limited to the following:

- Addition of new materials, suppliers, supply chains and tier detail records for Singapore site
- Perform changes/updates to existing materials, suppliers, supply chains and tier detail records for Singapore site
- Inactivate obsolete supply chains and tier detail records
- Request changes to child supplier and material records
- Perform mandatory periodic reviews of supply chains and tier details to ensure records are up to date and accurate based on the upcoming global audit plan and confirm that the suppliers to be audited and their respective ST records (Child Supplier Profile, Supply Chain and Tier Detail records) are accurate.

**Associated/Supportive ST Maintenance Activities**
- Support the update of materials/suppliers’ information in Supplier Transparency (ST) by:

- being the designated task owner for ST updates assigned in Global Change Management (GCM) Trackwise as part of new product introductions;
- Overseeing the completion and proper documentation of quality assurance activities where required as a task owner to document ST updates on the service provider and manufacturing aid material qualification forms.
- Perform ST data verification for mass uploads and mass updates as may be required (e.g. CAPA) and ensure timely closure of actions in accordance with committed audit/inspection/quality directive timelines by coordinating with site SMEs from (e.g. Quality, Global Procurement, PTO, Lab, IPT Operations, etc.) and collaborating with Quality for approval of records in MIDAS.
- Prepare ST related/assigned audit responses and corrective and preventive actions (CAPA).
- Ensure timely closure of actions in accordance with committed audit/inspection/quality directive timelines by coordinating with site SMEs from (e.g. Quality, Global Procurement, PTO, Lab, IPT Operations, etc) and collaborating with Quality for approval of records.
- Lead root cause analysis and investigations into process deviations related to ST
- Oversee Corrective and Preventive Actions (CAPAs) implementation and documentation in collaboration with other departments for process deviations related to ST
- Present information required during audits according to Standard Operating Procedures (SOPs)
- Develop Standard O