Job description

Division Overview:
Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.

Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.

Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.

Job Overview:
This Manager, QA Product Complaint and Recalls will be responsible for handling product complaints & recalls including complaint intake data, corresponding with contractors (Call Center) as required, process receipt of complaint samples, examine and evaluate complaints and retain samples for defects. Reviewing Investigation Reports, filling out closure letter templates and providing final responses to complainant/reporter will also be responsibilities of this position.

The successful candidate will have strong communication and customer service skills since this position deals with customers on a daily basis. This position requires a strong level of organizational and multi-tasking skills to handle a high phone call volume within the department. In addition, it is required to have an analytical mind to be able to analyze and summarize product complaint final investigations and be able to work independently and efficiently since the department requires meeting strict timelines.

This position is also responsible in the aiding of handling medical inquiries, the intake/processing of adverse drug events, as well as other projects as deemed appropriate.

This role is onsite in East Windsor, New Jersey with one (1) day a week remote.

Responsibilities:
Handling product complaints: initiating/receiving, processing and closing as per applicable standard operating procedures (SOP)
Prepare complaint samples for shipment to manufacturing unit for investigation
Interacting/doing follow-up with the customer/reporter on a daily basis to acquire information that may be required to effectively investigate a product complaint
Reviewing the final investigations received from the manufacturing units to ensure accuracy.
Following up with Corrective Action/ Preventative Action plans to ensure technical issues are being addressed
Provides information needed for status of recall, quarantines, and product returns to the recalling manufacturer.
Responds to inquiries made by management to resolve customer needs or concerns, including recall instructions, product listing information, and product returns and credit information
Collaborates with internal stakeholders, including Procurement, Category Management, and Customer Service teams as required
Supports Center operations with periodic FDA and internal audits
To assist in appropriately handling initial receipt of ADE and processing it as per applicable SOPs
As deemed necessary, to assist in the handling and processing of field alert reports to FDA
Completing the monthly Compliance Reports for Recalls and ADE's and submitting them to Global PVG in a timely manner
Responsible to prepare, update, maintain and compliance of the In-house SOPs, Quality System & Policy.

Qualifications - Skills & Requirements:
Must be cordial and responsible while talking to customers, complainants or other associates
Must be very organized and possess high standard work ethics
Effective communication, attentive listening is a must.
Skill to record the information received promptly and correctly on the appropriate documentation form is a must
Must have an experience to represent and support during FDA Inspection
Must be cooperative when assigned other responsibilities
Must be proficient in using Excel and Word

To protect the safety of our workforce, customers, and communities, the policy of the Company requires all employees and workers in the U.S. to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. All applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.

Education & Experience:
Minimum of Bachelor of Science or equivalent professional experience.
PharmD or Master’s degree (in Science / Pharmacy) is preferred but not required
3 to 5 years of experience working in Quality / Pharmacovigilance or related role in Healthcare industry
Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements:
No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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