GMP Compliance Officer
Hospira - Clayton, NC

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Hospira is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees.

The Hospira Clayton operation has over 300 employees and manufactures generic injectable drug products and devices. The drug products comprise of emulsion and solution products in both the small volume and large volume glass container configurations. All products manufactured at the Clayton operation are terminally sterilized.

The Hospira Clayton operation has an opening for a GMP Compliance Officer.

This individual is responsible for the internal audit program at the Clayton site, including maintaining the internal audit schedule, conducting or overseeing the audits, training new auditors, assisting with responses, and ensuring the site is in compliance with all regulations and corporate policies and procedures. This individual is also the audit backroom lead during corporate, customer, and external audits. In addition, this individual is responsible for the Clayton site Annual Product Quality Reviews (APQR) and supervises the Compliance Specialists that write APQR’s.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Maintain the internal audit schedule, conduct and oversee audits, and train new auditors, etc.

  • Serve as backroom lead during all corporate, customer, and external audits.

  • Assist the site with all audit responses; enter all audit records into Trackwise, including audit responses and CAPA’s; collect Clayton responses to sister site regulatory audit observations.

  • Supervise APQR writers and review all APQR’s prior to senior management review; ensure the APQR’s are completed per the schedule.

  • Assist with quality initiatives, Site Master File updates, change controls, projects, and other activities assigned to the Compliance Department.

Skills/Experience Education/Certification
· Bachelors Degree required.
· 7+ years of applicable experience in QA/Lab/Compliance/Manufacturing Quality in a pharmaceutical or regulated GMP environment.
· 1-3 years of Supervisory/Lead Role experience.
· Knowledgeable of cGMP guidelines and documentation requirements.
· Knowledgeable of FDA and other global regulations.
· Must be able to interact with personnel in various departments including Corporate and external auditors in a professional manner.
· Strong computer knowledge including experience with word processing and Trackwise.

Hospira - 22 months ago - save job
About this company
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Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...