Job Title:
Complaints Processing Analyst
Purpose:
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.
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.
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.
Benefits:
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.