【薪資面議】Job description:
Director Quality & Regulatory Affairs
*Company description
Since 1975, Flavine International has been linking
advanced API manufacturers with markets and pharmaceutical companies. We are thriving to add value to the business of both suppliers and
customers by locating and developing quality manufacturers and opening up new
markets. In managing our business, we put our best: Flavines' people.
Innovation, excellence, and integrity are our foundations to focus, to act and
to serve our customers. Our team invests time and assets to assist with
regulatory compliance of our manufacturing partners in order to ensure swift
development of new product and sustainable deliveries on a long-term basis.
*Responsibilities, QA/RA aspects
-
Evaluate
potential suppliers for their quality systems and compliance with appropriate
regulatory requirements of EU and US.
-
Preparation
and maintain CEP applications, ASMF, US DMF/VMF according to CTD format and
manage submissions in EU, US and China as business needs.
-
Perform periodic GMP
audit of Flavine suppliers and follow up on CAPAs in accordance with EU GMP
guidelines and Flavine’s internal procedure.
-
Assist and
provide regulatory and GMP guidance to Flavine’s suppliers to meet ever-growing
regulatory requirements and expectations.
-
Participate regulatory
inspections of Flavine manufacturing partners as needed including EU GMP
inspections and FDA inspections and contribute to positive inspection outcomes.
-
Coordinate CMC and tech
transfer activities among different stakeholders to ensure adherence to
expected timelines and compliance with applicable regulatory requirements.
-
Ensure the
liaison between Flavine’s marketing & sales department and suppliers to
tackle technical queries from customers.
-
Provide oral
and written translation support to Flavine’s suppliers if necessary to assure
regulatory activities are carried out smoothly.
-
Compilation
and establishment of technical agreements/quality agreements.
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Coordinate, administer and follow up on customer
complaints and change controls
*Requirements
- Degree:
Preference for Chemistry /Medicinal Chemistry/Pharmaceutical chemistry/Biology/Pharmacist
degree
- Experience: at
least 10 years’ experience across APIs and Formulations in the field of
quality and regulatory affairs
- QA experience: Profound knowledge in API, formulation
and pharmaceutical technology. General
knowledge and experience in cGMP, GDP, ICH, QA system
- RA experience: API DMF/CEP submissions
- Languages: Chinese and English
We’d be delighted to hear from you!
If you are interested in the position, send us your
application at ****************** and ********************.