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Job Details

QA Specialist II-151974

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 151974
Closing Date: 14 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

QA Auditor II   Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. ...

Requirements:

QA Auditor II   Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.   About the role   Due to continued success and growth, PPD is currently looking to recruit a QA Auditor to be based in our cGMP Lab in Athlone, Ireland. The role of QA Auditor within the Lab is to ensure the quality of lab data and reports. This is achieved through various audits of data and reports as specified by Standard Operating Procedures and by conducting inspections of Lab procedures.    Duties and Responsibilities:

  • Conducts and/or assists a variety of client, internal or GMP audits and regulatory inspections as requested by senior management
  • Leads process audits and internal audits
  • Participate as a co-auditor in more complex system audits
  • Identify process improvements
  • Identify OOS and deviations in processes
  • Responsible for investigations and non-confirmation reviews of deviations
  • Perform equipment and facility qualification review
  • Audits laboratory data for compliance with methods and standard operating procedures and report findings
  • Serves as resources to operational departments on audit or quality assurance subject matter
  • Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings 

Qualifications

Education and Experience
  • Bachelor's degree in Science
  • Min. 5 years’ experience in a lab based environment, with QA responsibility
  • QA experience should include process audits, audits of facilities, equipment qualification review, qualification documents (IQ, OQ, PQ) and validation.
Knowledge, Skills and Abilities:
  • Thorough knowledge of GMP and appropriate regional research regulations and guidelines
  • Demonstrated proficiency and led a range of project/process based or internal GMP audits to high standards required by management
  • Excellent oral and written communication skills
  • Strong problem solving, risk assessment and impact analysis abilities
  • Solid experience in root cause analysis
  • Flexible and able to multi-task and prioritize competing demands/work load
The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD at our Athlone labs. We offer a generous salary along with private medical insurance, pension and life insurance.   We look forward to receiving your application.    #LI-MH1

Apply for this job: QA Specialist II-151974

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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