Description
The Quality Assurance department has determined that due to its current and projected workflow, it will need the immediate assistance of a contractor who is capable of performing the following activities as a QA Contractor:Responsibilities:
- Maintain the Approved Vendor List and conduct vendor qualification, re-assessment evaluations as applicable
- Maintain vendor files in relation to Licenses, GMP Certificates, Quality Technical Agreements, TSE/BSE Certificates, as applicable
- Manage daily activities associated with the authoring, revising or Quality Technical Agreements for contract manufacturer/ laboratory, contract service providers (CSP) and warehouse and distribution facilities
- Manage daily activities associated with the Vendor Audit Program for contract manufacturer/ laboratory, contract service providers (CSP) and warehouse and distribution facilities
- Identify, schedule and ensure execution and completion of vendor audits in accordance with the Approved Schedule
- Manage daily activities associated with the Internal Audit Program
- Identify, schedule and ensure execution and completion of internal audits in accordance with the Approved Schedule
- Manage the CAPA program and enforce CAPA closure in a timely manner
- Assist with product complaints, as needed
- Author SOP's related to supporting functional areas, as needed
Experience:
- 5 - 7 years of experience in Quality Assurance with a focus in Vendor Management for a Global environment;
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Skills/Training:
- Communication Skills:
- Ability to work with a diverse group of personalities and individuals
- Good writing and verbal communication skills
- Strong technical background in the pharmaceutical, biotech, supply chain (distribution) or healthcare industry
- Knowledge of cGMP and ICH guidelines for a US, Canada and EU market
- Computer Skills:
- Knowledge of Software: MSWord, MSExcel, MSPowerpoint, MSOutlook, MSProject, Adobe Acrobat, desired
- Other Skills:
- Ability to work independently and multitasking
- Ability to set schedules and meet deadlines
Education:
B.S. or M.S. in a scientific discipline is preferred, or equivalent experience
To find out more about Real please visit www.realstaffing.com