Bausch Health

  • Sr Product Complaint Specialist

    Location US-NJ-Bridgewater
    Job ID
    10982
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Complaint Management

    Responsibilities

    • Reviews and approves complaints for Pharmaceuticals, Cosmetics, and Nutritional products.
    • Monitors Complaint Records in the system to ensure that the standard process is being followed and complaints are closed as required.
    • Performs complaint classification and severity assessments as required.
    • Manages communication and follow-up of Critical complaints.
    • Collaborates with Consumer Affairs, Drug Safety, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling.
    • Takes an active role in issue complaint resolution activities and decisions within the complaint group and cross functionally.
    • Provides training as SME on the complaint process.
    • Develops and maintains Work Instructions, Job Aides and Training Materials.
    • Develops new procedures and revises existing procedures as required.
    • Facilitates and supports the Complaint Review Board meetings/process as required.  
    • Escalates issues related to complaint trends, nonconforming product, etc. 
    • Drives CAPAs related to complaint management.  Conducts investigations into complaint trends to determine need for CAPAs or escalation. 
    • Works with Manufacturers to improve timeliness and quality of complaint investigations. 
    • Supports enhancements and upgrades to the Complaint System and performs User Acceptance Testing as required.

    • Leads/supports/implements complaint process improvement initiatives.

    • Provides Product Quality Complaints metrics/data/information as required.

    • Responds to ad hoc complaint requests for internal and external customers.

    • Provides direct support for internal/regulatory audits/inspections and responses to those audits/inspections.

    • Represents the Complaint Department on project teams, management meetings and internal/external forums.

    • Designee in the absence of the QA Manager, Product Complaints.

    • Other duties as assigned.

    Qualifications

    • Bachelor of Science or equivalent required.
    • Expert knowledge of GMP Regulations and ISO guidelines.
    • Ability to prepare written communications and communicate problems to management with clarity and accuracy.
    • Ability to understand safety, business (legal), and compliance risks related to complaints and in achieving performance objectives.
    • Ability to provide creative solutions to complex issues.
    • Delivers value-added business results through execution and controls.
    • Establishes good working relationships with colleagues and key stakeholders (internal and external).
    • Ability to write and review reports with clarity and brevity, and produce data reports with precision.
    • Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.
    • Critical thinking skills and strong attention to detail.
    • Strong analytical and technical skills.
    • Demonstrate initiative and drive action and results.
    • Excellent writing and presentation skills.
    • Ability to plan, multi-task and manage time effectively.
    • Must be a self-starter, action oriented, customer-focused, problem solver, be able to work independently, and have the ability to multi-task under strict deadlines.
    • Strong Computer and Information Technology Skills (Windows, Word, Excel, Access, Power Point and Visio.)

    Experience:

    • 5-8 years’ experience including Quality Assurance and/or Quality Control. Experience working in Pharmaceuticals, Medical Devices or other related or highly regulated industry required.
    • Previous product quality complaint handling experience required.

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