Job Description

ESSENTIAL JOB DUTIES: Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP ***GDP = Good Distribution Practice***
by supporting the following activities:

1) Annual supplier qualification

2) Support 3PL activities
a. Work Instruction Review/Approval
b. Nonconformance reports/Incident Reports Review/Approval
c. Quality discrepancy reports (Nonconformance Approval)
d. GDP QA input for Business Review Management

3) Upstream supply chain activities (product shipped from plants/suppliers to company 3PL)
a. Temperature Excursion Management, including but not limited to approval of temperature deviations for shipments sent to 3PL and update of the temperature excursion handling process
b. Product Damage Management, including but not limited to approval of deviations for shipments sent to 3PL and update of the product damage handling process

4) Document Management and archival of the GDP QA documents in Veeva/eQMS

5) Supports with any GDP related activities

REQUIRED:
1) BA / BS in a science field, with minimum 5 years of pharmaceutical industry experience, minimum 3 years of QA experience.
2) Knowledge of GDP and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
3) Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the company groups and with external stakeholders.
4) Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.

PREFERRED:
1) Experience using GxP Documentation systems (Such as Trackwise (Digital), Veeva, SAP systems).
2) Direct experience in Quality Assurance function, GDP preferred
3) Working knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).
4) Proficient with MS Excel, WORD, PowerPoint.

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