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.
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.)
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.