Sr. QA Specialist, GMP Audit

San Jose  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

We are urgently seeking an experienced GMP Auditor. This position is with a Small Molecule Oncology company, who is currently rolling out their first drug into commercialization. Due to this production has been severely ramped up and they are in urgent need of an experienced pharma/biotech GMP auditor to oversee their API Manufacturer's.

Responsibilities Include:
  • Perform internal and external GMP audits to ensure that quality systems are robust and in compliance with regulatory requirements.
  • Execute audits in accordance with established audit processes.
  • Maintain audit schedule to ensure quality oversight of CMOs, suppliers and internal functions.
  • Author, implement and maintain SOPs in accordance with GMP Compliance


Specific Skills/Experience:
  • 2 years of hands-on auditing experience in a regulated cGMP environment
  • Must have an understanding and application of cGMP and Q7.
  • Expert knowledge of 21 CFR Part 210,211
  • ASQ certified auditors are preferred


Please apply if you think your background could be a good fit and I will reach out shortly.

To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
13.04.2014
Project ID:
694877
Contract type
Permanent
To apply to this project you must log in.
Register