senior quality & Regulatory Affairs specialistRoche

Job Description
The Position
Responsible for overall quality affairs, with support from the Affiliate Quality Head (AQH), to implement and perform necessary quality activities in order to fulfill requirements of local regulations, and Roche Diagnostics Global Quality principles and policies.
Essential Duties and Responsibilities:
Local Safety Officer
Establishes the local case handling process to assure quality and timely execution of product complaints and inquiries
Conducts the training of the local personnel on complaints management
Verifies the locally identified Potentially Reportable Incident cases to ensure proper escalation
Manages the Safety Board Notifications (SBN) and Quality Notifications (QN) in
accordance to Modular Quality Management Systems
Supports other functions in the management of other affiliates notifications
Ensures SBN feedback is provided confirming that the notification had been received, reviewed, and the required actions have been completed
Performs product recall activities related to quality concerns
Liaise with local business area managers to ensure that any product safety issues are properly managed
Collects and reports to Roche Global Safety all adverse events occurring affiliate and associated with Roche products on an accurate and timely manner
Ensures accurate and timely submission to Health Authorities of all adverse events that occurred in the affiliate from all sources
Interacts with the Health Authorities and health care professionals product safety related matters
Deputy Affiliate Quality Head (DAQH)
Supports the AQH in ensuring that the site complies with the applicable RD Quality Standards and local regulatory requirements with regard to- Training and Communication, Monitoring of Q&R Metrics, Notifications and Internal/External audit
Informs affiliate about new/updated Modular Quality Management System and that, where applicable, these are incorporated into local procedures and applicable staff is trained
Regulatory Affairs Support
Assist the RA team on Health Authorities inspection (DDB/OMB/FDA) by assuring the affiliate is operating in an inspection ready manner at all times
DIAGNOSTICS DIVISION
Supports the Regulatory Affairs team in ensuring compliance with the local labeling requirements of the FDA
Reporting to
Quality and Regulatory Affairs Leader
Liaises with
FDA, DOH, DENR, MDI and other government agencies that may apply
Relevant internal team members including Customer Service, Sales, Marketing, Supply Chain and other departments/areas as required
Regional and Global Q&R functions or other departments as required
Language Skills
Proficiency in both English and Filipino (written and spoken) Education and/or Experience
Bachelor's/Master degree in Pharmaceutical or Science related field (preferably medical laboratory related)
Preferably with 2-3 years of experience in Quality Management System
Multi-national companies experience is an advantage
Other Skills and Abilities
Personal Computer Skill (Microsoft Office Application)
Effective Communication and Writing Skill
Good Interpersonal Skill
Creative Problem Solving Skill
Customer Handling Skill
Time Management Skill
Ability to work independently and as team player
Self-Initiative and Pro-active
Administrative Skill
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.