Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Pharmaceutical Complaint Vigilance Analyst - Manufacturing\gmp
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Sales, Marketing
Projektbeschreibung
Pharmaceutical Complaint Vigilance Analyst - Manufacturing/GMP
Leading global pharmaceutical company require a Complaint Vigilance Analyst within their Business Quality unit to manage complaints and communicate with customers and external business partners.
Responsibilities will include:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, MDR reportability, correctness and
consistency of categorization.
- Assign complaints to appropriate investigatory sites.
- Communication of potential serious PQC's in a timely manner, as appropriate.
- Retrieval of field samples (US only), as applicable.
- Ensure all relevant complaint data is obtained.
- Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales
- Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Participate within and monthly execution of PQC complaint monitoring to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
- Deliver training for colleagues and customers on complaint handling process, product specific
The ideal candidate will be expected to:
- Possess knowledge of cGMPs, regulations and risk management requirements to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System.
- Exhibit strong communication skills in order to collaborate with Business Partners to ensure appropriate complaint handling.
- Deliver appropriate training to complaint management system end users.
- Work independently, challenges the status quo, identifies gaps and process improvements. Participates within
special projects
- Maintain and update applicable department procedures via the Document Management System
Please apply now for more details!
Leading global pharmaceutical company require a Complaint Vigilance Analyst within their Business Quality unit to manage complaints and communicate with customers and external business partners.
Responsibilities will include:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, MDR reportability, correctness and
consistency of categorization.
- Assign complaints to appropriate investigatory sites.
- Communication of potential serious PQC's in a timely manner, as appropriate.
- Retrieval of field samples (US only), as applicable.
- Ensure all relevant complaint data is obtained.
- Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales
- Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Participate within and monthly execution of PQC complaint monitoring to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
- Deliver training for colleagues and customers on complaint handling process, product specific
The ideal candidate will be expected to:
- Possess knowledge of cGMPs, regulations and risk management requirements to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System.
- Exhibit strong communication skills in order to collaborate with Business Partners to ensure appropriate complaint handling.
- Deliver appropriate training to complaint management system end users.
- Work independently, challenges the status quo, identifies gaps and process improvements. Participates within
special projects
- Maintain and update applicable department procedures via the Document Management System
Please apply now for more details!
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb