Lead Consultant, Pqc

hace 6 días

San José, Costa Rica Genpact A tiempo completo

With a startup spirit and 90,000+ 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 all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us._

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- Transformation happens here. Come, be a part of our exciting journey_

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- Are you the one we are looking for?_

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- 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, GMP, GDP, quality & compliance and complaint handling is required._

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- Responsibilities_

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- _Interacts with complainants and obtains essential information required to document technical complaints_

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- _Provides customer service and support to meet the needs of the complainants_

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- _Identifies and confirms inquiries as product technical complaints._

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- _Evaluates complaints for severity and risk to public safety._

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- _Notifies interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints._

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- _Monitors and tracks sample receipt from critical complaints._

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- _Ensures complaints are reviewed and processed within a timely fashion._

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- _Prioritizes complaints for data entry and processing into the global database._

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- _Utilizes the customer service database to oversee complaint identification and processing._

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- _Monitors complaint activity for assigned manufacturing sites._

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- _Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations._

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- _Identifies complaints for field alert reporting_

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- _Performs QC Checks_

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- _Understands US FDA complaint regulations for drug products and medical devices._

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- _Performs file review and administrative closure for individual complaints._

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- _Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity._

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- _Monitors open complaint activity for each manufacturing site._

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- _Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints._

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- _Identifies and reports adverse events within one business day to Pharmacovigilance._

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- _Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management._

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- _Participates on ad-hoc teams regarding product-specific complaint issues._

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- _Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits._

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- _Understands product specific information regarding common product complaints._

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- _Understands department process flows and complaint databases._

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- _Provides feedback to customers regarding complaint investigations._

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- _Performs other duties as assigned._

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- Qualifications we seek in you_

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- Minimum qualifications_

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- _Bachelor’s degree from an accredited four-year college or university_

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- _Area of specialization: Health or Life Scuences_

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- _Associate’s degree from an accredited two-year college or technical school_

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- _Area of specialization: Health or Life Sciences preferred_

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- KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE_

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- _Bachelor degree /Associate degree in science or related field of study_

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- _Experience within the pharmaceutical industry. Will consider an advanced degree in lieu of years of experience._

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- _Strong Verbal and Written Communication Skills in English_

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- _Problem Solving Skills_

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- _Adept at Attention to Detail_

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- _Strong understanding of Good Documentation Practices_

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- _Good organizational skills_

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- _Analytical skills_

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- _Self-motivated/directed_

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- _Computer literate—proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools._

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- _Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics_

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- _Project and Time Management Skills_

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- _Interpersonal skills-must be proactive, personable, flexible, team-oriented_

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- _Customer Service Skills_

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- _Ability to multitask in a highly stressful environment_

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- _Ability to operate in a constantly changing environment_

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Job_**_Lead Consultant_

**_ Primary Location_**_Costa Rica-San Jose_

**

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