Job Details

ID #43101599
State New Jersey
City Shorthills
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source ReqRoute, Inc
Showed 2022-06-16
Date 2022-06-15
Deadline 2022-08-14
Category Et cetera
Create resume

PQC Pharma Analyst

New Jersey, Shorthills, 07078 Shorthills USA

Vacancy expired!

Job Description: 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 department PTC 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 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 to Pharmacovigilance.
  • Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.
  • Participates on ad-hoc teams regarding product-specific complaint issues.
  • Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
  • Understands product specific information regarding common product complaints.
  • Understands department process flows and complaint databases.
  • Provides feedback to customers regarding complaint investigations.
  • Performs other duties as assigned.
KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE
  • Minimum of 3 to 5 years of related experience within the pharmaceutical industry.
  • Strong Verbal and Written Communication Skills
  • 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

Kapil Bhatia

ReqRoute Inc.website: http://www.reqrouteinc.com/careers

Vacancy expired!

Subscribe Report job

Related jobs