OVERVIEW 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. Provides consultation, mentoring and 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. Consults with PRA staff for interpretation of regulations. May have responsibility to support specific operations such as:
Clinical Pharmacology Unit
Level III auditor independently conducts the following activities as assigned by QA management:
Performs contracted, routine and complex audits according to client expectations and/or PRA SOPs.Often assigned to lead a team of auditors and/or conduct complex audits independently
Plans and ensures audits are scheduled.
Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.
Reports observations/findings according to client or PRA SOPs and report templates.
Tracks, collects and reports responses and corrective actions per contract with client or PRA SOPs.
Documents closure of audit
Interprets regulations and guidance documents governing GxP and applies the interpretation for PRAHS staff.
Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations and new trends and proposed changes to regulations.
Shares questions and issues posed to QA with global PRA QA staff as necessary to insure best advice is obtained.
Compiles response from QA staff and literature and replies to customer and more broadly throughout PRAHS as needed.
Facilitates client audits and regulatory inspections of PRA to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations.
Assigned to participate in QA projects such as management of issue escalations, CAPA projects, or other QA initiatives.
Read, write and speak fluent English; fluent in host country language required.
5+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
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 require
Experience working within a clinical research organization.
Experience in Quality Assurance function is strongly preferred.
Clinical site monitoring, GxP quality assurance auditing, and GxP regulations.
Computer Systems Validation (CSV) experience.
Process improvement experience.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Telecommuting is allowed.
About PRA Health Sciences
Who are we?
We Are PRA.
We are 15,000+ 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 mentor and leader- because being a report pusher isn’t your style!
You like to stay hands on with your audits- (our Managers up to the VP still audit!)
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.