Pharma product quality complaints (pqc) analyst

Descripción general

Description:

This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics and combination products. Knowledge of US regulatory requirements, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), quality & compliance and complaint handling is required.


Responsibilities:

-Interacts with complainants and obtains essential information required to document technical complaints.
-Provides customer service and support to meet the needs of the complainants.
-Identifies and confirms inquiries as product technical complaints.
-Evaluates complaints for severity and risk to public safety.
-Notifies interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints.
-Monitors and tracks sample receipt from critical complaints.
-Ensures complaints are reviewed and processed within a timely fashion.
-Prioritizes complaints for data entry and processing into the global database.
-Utilizes the customer service database to oversee complaint identification and processing.
-Monitors complaint activity for assigned manufacturing sites.
-Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations.
-Identifies complaints for field alert reporting.
-Performs QC Checks.
-Understands US FDA complaint regulations for drug products and medical devices.
-Performs file review and administrative closure for individual complaints.
-Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity.
-Monitors open complaint activity for each manufacturing site.
-Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints.
-Identifies and reports adverse events within one business day

Requisitos para aplicar

Minimum qualifications:

-Bachelor’s degree in any career related to Health or Life Sciences.
-Minimum of 3 to 5 years of related experience within the pharmaceutical industry. Will consider an advanced degree in lieu of years of experience.
-Advanced English level (C1), verbal and written.
-Problem Solving Skills.
-Adept at Attention to Detail.
-Strong understanding of Good Documentation Practices.
-Good organizational skills.
-Analytical skills.
-Self-motivated/directed.
-Computer literate—proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools.
-Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics.
-Project and Time Management Skills.
-Interpersonal skills-must be proactive, personable, flexible, team-oriented.
-Customer Service Skills.
-Ability to multitask in a highly stressful environment.
-Ability to operate in a constantly changing environment.