- 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.
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