Functional Quality Specialist II
Functional Quality Specialist II
Posted on :
25-02-2025
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Job Description
Job Title: Functional Quality Specialist II
Job Location: Pune Maharashtra India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: Entry level
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience Fortrea provides pharmaceutical biotechnology and medical device customers a wide range of clinical development patient access and technology solutions across more than 20 therapeutic areas. Conducting operations in 100 countries Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview
It is the responsibility of the post holder to provide all clients both internal and external with the appropriate quality of service in a safe and costeffective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974 the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary Of Responsibilities
Fortrea Is Proud To Be An Equal Opportunity Employer
As an EOE/AA employer Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data please see our Privacy Statement.
If as a result of a disability you require a reasonable accommodation to complete your job application preemployment testing job interview or to otherwise participate in the hiring process please contact: . Please note that this email address is only for job seekers requesting an accommodation. Please do not use this email to check the status of your application.
Job Overview
It is the responsibility of the post holder to provide all clients both internal and external with the appropriate quality of service in a safe and costeffective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974 the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary Of Responsibilities
- Take ownership of assigned aspects of quality reviews on projects.
- Compile metrics and identify quality trends.
- Assist in addressing periodic client quality reviews and other adhoc client quality findings.
- Prepare initial drafts of Corrective and preventive actions.
- Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions labeling / regulatory documents for Fortrea clients e.g. Annual Reports (IND and other) PSURs PADERs Clinical Study Reports Core Data Sheets USPI centralized SPC’s Med Guides etc.
- Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e. unsolicited reports).
- Manage and review expeditable adverse events product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
- Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence to that effect in coordination with the project managers.
- Contribute to process reviews own certain aspects of the reviews and use the results to help identify process improvements and develop process standards.
- Contribute to designing and tracking training schedule and training material for new hires and existing team.
- Help initiate discussion forums on Quality errors within assigned project and identify process improvements share best practices across projects.
- Assist in coordinating respective client or external audits of the assigned projects.
- Draft sections of the Quality Management Plan for assigned project.
- Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.
- Implement and promote use of consistent efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables.
- To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call email fax etc.
- Review recorded information that may be received over the telephone call email fax etc.
- Execute drug safety data management processes – a combination of call intake review call dialogue documentation review and case followup.
- Guide safety associates in managing voice calls (as required).
- Perform any other support activities as assigned – tracking various types of information and metrics ongoing QC of defined process steps training reconciliation of data from multiple sources.
- Perform Analysis of data and if required suggest strategies for process improvement/excellence.
- Perform and Review of analysis of data performed and drive strategies for process improvement/excellence.
- All other duties as needed or assigned.
Fortrea Is Proud To Be An Equal Opportunity Employer
As an EOE/AA employer Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data please see our Privacy Statement.
If as a result of a disability you require a reasonable accommodation to complete your job application preemployment testing job interview or to otherwise participate in the hiring process please contact: . Please note that this email address is only for job seekers requesting an accommodation. Please do not use this email to check the status of your application.
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Employment Type
Full Time
Key Skills
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