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Quality Assurance Auditor
Offer modified on 07/22/2008

Basic Functions:

To conduct audits/inspections of new and existing suppliers and vendors in support of new and commercialized products. Responsible for scheduling, performing, and reporting the supplier/contractors inspection results.

Education/Work Experience:
  • Bachelor Degree in sciences (i.e.: chemistry, microbiology)
  • At least 5 years of progressive challenging QA/QC experience in the pharmaceutical industry with at least 3 years of auditing experience.
  • In-depth knowledge of cGMP, cGLP, Aseptic Processing, as well as FDA trends regulations, and guidelines.
  • Capable to work independently and part of a team, able to coordinate multiple projects.
  • Must possess exceptional communication, organizational skills
  • Ability to travel oversees (50 % of the time)
Principal Accountabilities:
  1. Prepares audit schedules and conducts QA/QC audits/inspections as directed, related to Sagent’s suppliers including contract manufacturers, active pharmaceutical ingredients, contract laboratories, etc.
  2. Assist in monitoring, scheduling, conducting, and reporting of cGMP activities for Sagent’s suppliers and partners.
  3. Communicate the results of the inspections to the manufacturing site and applicable Sagent personnel.
  4. Assures that the suppliers/vendors/contractors meet the internal and regulatory requirements.
  5. Maintain audit and correspondence records to evaluate the process trends and potential non-compliance to the quality requirements.
  6. Coordinate and perform compliance projects as required by the management. Projects may include product reviews, equipment and process qualifications, change control, etc.
  7. Review and assess the audit responses against the current industry standards and guidelines to ensure that sufficient controls are in place and meet Sagent’s Quality standards and requirements. Follow up on the implementation of the corrective actions associated with the audit observations until completed.
  8. Provides quality evaluations of suppliers and contractors to reduce the risk of data or site being unacceptable to Sagent quality standards and FDA requirements.
  9. Ensures that the audit budgets are not exceeded by advance scheduling and ensuring that multiple audits are performed in the same geographical area in order to minimize expenses.
  10. Serve as QA representative on multi site multi-function project teams.
  11. Support and participate in project management meetings as necessary, to ensure that the new product launches are carried out in accordance with Sagent’s quality standards.
 
Reference : Letter Required
Contract type : Full Time
Job(s) available : 1
Experience required : 5+ Years
Studies level required : Bachelors Degree
Working place : Schaumburg, Illinois
Creation date : 07/02/2008

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