# SOQ Associate

**Company**: Pfizer
**Location**: Shanghai
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/China---Shanghai---Shanghai/Supply-Operation-Quality-Associate_4966533?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_282e77be-02b

## Description

The SOQ Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations.

The SOQ Associate will work closely with relevant local stakeholders, such as Global Regulatory Sciences (GRS), Global Supply Chain (GSC), Medical, and PGS sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operation of the Pfizer China business.

**Quality Assurance & Inspections and Internal Audit**

- Contributes to ensuring the timely implementation of applicable quality management systems processes, global and local procedures, work instructions, Job Aid and controlled documents within the PCO.

- Participates in assessing new quality system/local regulatory requirements and adjust/enhance local systems and processes when required.

- Contributes to ensuring that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues.

- Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately.

- Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions.

- Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO.

- Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and ensures action implementation within the agreed timelines.

**Local Product Disposition & Resolution of Product Quality**

- Execute the local release process for Products under the PCOs distribution license.

- Supports the coordination of all Product repackaging and/or relabeling activities in the PCO and at the third-party packaging site.

- Actions Quarantine Alert Notifications promptly, as required.

- Ensures quarantine shipments are managed compliantly according to procedures, as required.

- Complaint Handling – Perform Intake, issue correspondence letter as required.

- Identifies and investigates quality deviations and works with cross-functional teams to implement CAPAs.

**Supplier Quality Management**

- Assist with the management of GMP/GDP vendors including qualification, quality oversight in accordance with internal and regulatory requirements for GMP/GDP activities.

- Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required.

**Leadership Skills**

- Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint.

- Development and Maintenance of Quality culture, within the team and organization.

**Local Requirements**

- Support to establish and update supplier quality files, sales customer quality files and product quality files under PCO distribution license.

- Responsible for the collection, feedback and processing of drug regulation and quality information.

**关键绩效指标 （KPI）**

- Works according to relevant SOP / WI

- SIR deviations, Regulatory Commitments, CAPA, CR, QAP, Complaints: monitored by KPI, VM, QRM and Supplementary metrics.

**资格**

- A minimum Tertiary Education in Science, Pharmacy or related discipline

- A minimum of 3 years in the pharmaceutical industry in a quality role

- Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.

- Experience in, GMP, GSP and QMS.

- Technical writing and reporting.

- Licensed Pharmacist is preferred

- Fluent in English (written & verbal)

- Experience in Quality administered systems.

- Excellent computer system skills – Word and Excel essential.

## Skills

### Required
- GMP
- GDP
- QMS
- Quality Assurance
- Auditing
- Technical writing
- Problem solving

### Nice to have
- Licensed Pharmacist
- eQMS

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/China---Shanghai---Shanghai/Supply-Operation-Quality-Associate_4966533?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)