Complaint Manager

Description

Complaint Manager

Project information's:

Start may 2017

Duration 6 months, with potential extension

Location 100% on site in Basel

Major tasks and responsibilities of position

• Resolve customer complaints from the market (class III, IV and V) or internal complaints as related to product manufactured, released and distributed, which must take into account all manufacturing and distribution processes, quality testing and customer requirements with minimum supervision. Assist and contribute to the resolution of significant customer complaints from the market (class I and II).

• Oversee and assess investigations in bulk drug substance, drug product, and quality control. Assures timely resolution of issues and implementation of corrective/preventive measures using scientific and GMP and product regulatory compliance principles for root cause analysis and product impact assessment. Use scientific judgment to ask key questions during investigations intended to identify root cause of issues.

• Participates on teams to provide scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply taking into account the different legal status of our portfolio.

• Contribute to the preparation local SOPs for complaint management system and ensure compliance with global company's requirements.

• Performs monitoring and trending analysis of complaints and associated KPI's relevant to the complaint management process.

• Maintains awareness of current GMP trends and manufacturing processes.
• Supports continuous improvement within the Quality Unit, including optimization of complaint process and systems based on specific multi-status portfolio (medicinal products, food, cosmetics, medical devices, commodities).
• Participates to and provides support for regulatory agency inspections and requests

Work relations

Focus is internal and external. Interacts with project team member's peers and Department Heads.

Maintains an external network in field of expertise.

Demonstrates integrity and firm commitment to company beliefs and values

Background

Technical background or complaint handling background, ideally also having experience in pharmaceutical industry

At least 2-3 years working experience in a similar role

Please contact me for further details on the job and the company.

Sabina Keel