PRAHS

Returning Candidate?

2017-43852

2017-43852

Title 
Quality Assurance Auditor - GMP
Job Locations 
-
US-Remote
Posted Date 
11/25/2017

More information about this job

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 14,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

 

Who are you?

 

You are a strategic thinker with a great attention to detail. – nothing gets past you!

You like variety. – The same old tasks day to day just don’t get you up in the morning!

You have experience with a full range of audits and GxP services.

You believe in consistently delivering quality with each audit you perform.

You have experience traveling (and enjoy being on the road!) to conduct onsite audits.

At the end of the day, you want to work for a company that values your education, knowledge and experience…

a company that is ultimately better with you on their team.

That company is PRA.

Responsibilities

What will you be doing?

 

Long story short, you will work closely with internal PRA groups to assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to internal process audits, pharmacovigilance system audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), country office audits and audits of vendors used to support PRAHS services.

 

Still interested? Great, there’s more…

You will frequently interact with internal PRA groups consultating, mentoring and providing compliance for the organization on GxP areas (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. You will aslo consult with PRA staff for interpretation of regulations.

 

May have responsibility to support specific operations such as:

· Clinical Pharmacology Unit

· Bioanalytical Laboratory

· Logistics

· GMP Pharmacy

· Computerised Systems

Qualifications

What do you need to have?

 

Great question…

 

  • 3-5 years of working GMP auditing experience both internal and vendor audits
  • Clinical site auditing and process/procedural auditing against GxP regulations
  • 2 years of GMP QA manufacturing with production audit experience, including experience conducting internal audits and manufacturing type vendor audits.
  • Familiarity with GCP and CROs
  • Regulatory Authority Experience (FDA)
  • Process improvement experience
  • Experience working with/within a clinical research organization preferred.
  • Excellent verbal and written communication skills, interpersonal skills.
  • Excellent organizational skills.
  • Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas. An undergraduate degree, its international equivalent in health sciences, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
  • Read, write and speak fluent English; fluent in host country language required

 

Preferred Qualifications

  • Regulatory Authority Experience (EMA, MHRA)
  • ASQ or ISO Auditor Certification
  • Advanced degree
  • Expertise in GCPs
  • Experience working at a CROs
  • Aseptic/Sterile Experience

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

 

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!