ProPharma Group
This listing was posted on ProPharma Group (via Broadbean).
Quality Assurance, Post-Market PQC
Location:
Chicago, IL
Description:
Position Responsibilities * Assure complaint records meet global requirements. * Product complaint documentation, investigation, and review of all non-medical complaint content. * Responsible for reviewing Medical complaints that involve a non-medical quality related event. * Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. * This requires good analytical skills, technical writing and good documentation. * Responsible that complaint files meet all regulatory requirements. * Identification of potentially reportable events and notification to appropriate functional groups and management. * Interface with Third Party Manufacturers, health care professionals, general public, internal customers, client functional areas and regulatory agencies. * Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.Position Qualifications * Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. * Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. * Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. * Solid written/verbal communication and organizational skills. * Knowledge and application of computer systems for word processing and complaint management. * Ability to work with cross-functional teams and to interact effectively with peers, management, and customers. * Bachelor's Degree required or 1-2 years of relevant work experience. * Preferred degree in technology or scientific background (MLT, LPN, RN). * 1-2 years' work experience in a cGMP related industry or in a clinical setting is preferred*4 to 5 month contract opportunity.
Company:
Propharma Group
Posted:
September 27 on Broadbean
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More About this Listing: Quality Assurance, Post-Market PQC
Quality Assurance, Post-Market PQC is a Quality Assurance QA Job at Propharma Group located in Chicago IL. Find other listings like Quality Assurance, Post-Market PQC by searching Oodle for Quality Assurance QA Jobs.
Quality Assurance, Post-Market PQC is a Quality Assurance QA Job at Propharma Group located in Chicago IL. Find other listings like Quality Assurance, Post-Market PQC by searching Oodle for Quality Assurance QA Jobs.