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Job Details

QA Auditor II - Athlone (2000 EUR relocation bonus)-144914

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 144914
Closing Date: 17 Aug 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...

Requirements:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.   Our Athlone cGMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. For this passion we also propose a relocation bonus of 2000EUR.
 
About the role:
 
Due to continued success and growth, PPD is currently looking to recruit a QA Auditor II to be based in our cGMP Lab in Athlone, Ireland. The role of QA Auditor II 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 leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Performs directed site audits, facility, vendor and/or sub-contractor audits
• Provides GxP consultation and support to PPD project teams and external clients
• Leads process audits and may participate as a co-auditor in more complex  system audits
• Performs other types of QA audits or activities (e.g. database audits, clinical  study report audits, sample results tables, process improvement)
• Serves as a 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 or equivalent and relevant formal academic / vocational qualification

• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training.

 

Knowledge, Skills and Abilities:

 

• Meets competencies for QA Auditor I plus:

• Thorough knowledge of GxP and appropriate regional research regulations and guidelines

• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor 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

• Above average negotiation and conflict management skills

• Flexible and able to multi-task and prioritize competing demands/work load

• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

• Perform QA audits of facility records and issue written audits.  Records include: Equipment maintenance and calibration work, new or relocated equipment qualification documents (IQ/OQ/PQ), and software validation.

 

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.

This is an ongoing search.  Suitable candidates will be contacted accordingly.

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*IndeedPPDEMEA1

Apply for this job: QA Auditor II - Athlone (2000 EUR relocation bonus)-144914

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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