Regulatory & Compliance Remediation Support - (REF6962O)

Company: ProPharma Group
Location: Rocky Mount
Posted on: September 7, 2020

Job Description:

Job Description Responsible for gathering/communicating (cross-functional team) any known gaps or misalignments identified through technical transfer of molecule. Establish folders and templates for molecule on SharePoint. Populate the Data Assessment tables with product name, list number, test attributes and test method as provided in the source specifications. Schedule a review meeting with Regulatory, Quality and any other required supporting team members to review and finalize the Data and Gap Assessments. Draft a gap remediation plan for each gap documented in the Gap Assessment. Prepare a redline of the impacted documents to be reviewed by the Core team with the remediation plans. For remediation activities that require a change control only, you will be responsible for the change control. Update the weekly tracker (minimally) for each molecule assigned to youQualificationsQualified candidates must have:B.S./B.A. preferably in life sciences or healthcare, or equivalent experienceFive years' experience in Medical Information, or a quality operations or call center role, preferably in the health care, pharmaceutical or medical device industries.Previous Quality Assurance or audit experience preferredExcellent attention to detail and focus on quality.Strong verbal and written communication skills.Excellent workload management skills.Ability to prioritize workload and meet deadlines.Excellent questioning and listening skills.Capable of resolving conflict in a constructive manner.Able to work in a collaborative manner with colleagues in other departments to achieve Company goals.Ability to speak effectively in interpersonal situations and presentations before groups of employees and clients.Possesses a service-oriented approach.Flexible and proactive toward changing needs.Good understanding of quality assurance regulations and guidelines, preferably related to cGxP.Quality Assurance with experience in internal and external audits, and maintaining regulated documents and training files, preferable related to cGxP.Knowledge of FDA regulations for adverse event and product complaint reporting.Proficiency with use of MS Word, Excel, and PowerPoint.Additional InformationAll candidates must be legally eligible to work in the United States.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Rocky Mount , Regulatory & Compliance Remediation Support - (REF6962O), Other , Rocky Mount, North Carolina