Jobs Opening
Position ID :Q-IN-2017-PS035
Date Posted : 03-16-2017 (mm-dd-yyyy)
Jobs Title : Pharmacovigilance Quality Assurance - Intern
No of Openings : 2

Job Classification: Internship

Location:
Qtech Solutions Inc.
3 Executive Drive, Suite 320
Somerset, New Jersey USA 08873.
Contact:
Director Operations
NJ Phone : 732-770-4100 Fax: 888-532-0210
Email      : hrs@qtech-solutions.com

Job Duties

This Unpaid Internship is conducted for 12 Weeks to Fresh and Alumni Students. Selection for Internship is based on GPA and Interview performance. Our Placement division supports various pharmaceutical, healthcare and financial firms, by providing staffing resources meeting cost efficiency, time saved and commitment to their hiring needs. Successful Intern, will be provided an opportunity to work at our client sites on contract as full-time employee of Qtech with benefits.

  • Establish and maintain optimal relationships with internal and external stakeholders (ex. PV Operations, PCYC Quality Groups, partner Company Quality and Compliance counterparts).
  • Support in advancing the framework/systems supporting PV Quality and Compliance.
  • To include but not limited to process documents, audit/inspection data, compliance monitoring/reports, contracts, and metrics related to PV Quality and Compliance.
  • Coordinates document control process with new or revised procedures, ensuring document control and training requirements are fulfilled.
  • Participate/support in business partner, vendor, and internal process audits. Support/lead assigned tasks by management.
  • Support Company’s Quality risk-based program related to company activities
  • Collaborate with company management and Quality Assurance (QA) to prepare for, participate in, and track outcomes (findings) from audits/inspections.
  • Contributes to the review of all findings related to drug safety activities from audits/regulatory inspections (internal company and PV TPs). Ensure CAPAs are developed and implemented when appropriate.
  • Support the development and reporting of company metrics and monitor efficiency, quality and adherence to regulatory and contractual obligations with TPs. Enhance method of tracking TP compliance to safety agreements.
  • Maintain a process to ensure TP contracts contain appropriate adverse event reporting language.
  • Collaborate with company, QA and other cross functional departments to develop/maintain quality system-related SOPs/Work Instructions/Forms.
  • Support management of DSP nonconformance procedures, including identification, investigation, tracking/trending and reporting. Perform investigations and prepare nonconformance documentation.
  • Contributes to process improvement and educational initiative.
  • Provide training on PV Quality and Compliance related activities.
  • Perform other activities as directed by management.
 
Education : Medicine, Nursing (RN), PharmD, Pharmacy, Public Health, Pharmaceutical and Industrial Chemistry.
 
Experience : 0-2 years
 
Application End Date: 06-16-2017 (mm-dd-yy)
 

Please forward Your resumes along with position-ID to hrs@qtech-solutions.com

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