Genpact is a professional services firm that creates lasting, impactful transformation. With a startup spirit and 95,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling upon motivated and passionate individuals to drive real world impact for some of the world’s biggest brands. Come, join us in our relentless pursuit of a world that works better for people.

PQC Associate/Analyst

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 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.

Qualification:

• 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

Educational Background:

• Bachelor’s degree in a science discipline preferred.
• High-school level command of spelling, grammar, and math, and/or basic vocational skills training (e.g., high school diploma, general education degree)
• Up to two years of formal post-high school specialized trade school, technical school, or college
• Area of specialization:
• Associate’s degree from an accredited two-year college or technical school
• Area of specialization: Health or Life Sciences preferred

Please note that this is a contract role providing services to Genpact through our direct sourcing partner, the Ian Martin Group, who manages Genpact’s Contractor Talent Community. If you are selected for this role, you will be employed by Ian Martin and will not be an employee of Genpact.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit https://www.livehire.com/careers/genpact/jobs

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