Company Overview
Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs.
Job Title: Complaints Processing Analyst
The Complaints Processing Analyst will report directly to the complaints manager and coordinate the handling of customer complaints investigations, trending, and analysis for all commercial & clinical products, working with internal departments on Root Cause Problem Solving cases to ensure implementation of robust Corrective/Preventive action plans and tracking these to completion.
Key Responsibilities:
* Assure complaint records meet global requirements.
* Product complaint documentation, investigation, and review of all non-medical complaint content.
* Responsible for reviewing medical complaints that involve a non-medical quality related problem.
* Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
* Identification of potentially reportable events and notification to appropriate functional groups and management.
* Serve as main resource for the team or a subject matter expert on complaint handling.
* Liaise with site complaint investigation team to achieve closure of complaint cases in a timely manner.
* Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy.
Requirements:
* Bachelor Degree in Sciences or related field.
* 1-2 years previous experience in pharmaceutical industry.
* Previous experience in the use of SAP and Trackwise and Document management systems is desirable.
* Knowledge of global regulatory requirements for pharmaceutical, medical device and combination products.
* Proficient computer skills including Word, Excel.
* Strong CAPA knowledge, decision making and critical thinking abilities.
* Excellent written, communication and interpersonal skills.
* Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
* Ability to work with cross-functional teams and to interact effectively with peers, management and customers.
* Good time management and organizational skills.
About Us
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.
If you are a motivated pharma professional seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.