TRABAJO REGULATORY QA

The  associate director – regulatory submissions is responsible to lead a worldwide regulatory submissions delivery team within iqvia translations...

Ability to interpret global regulatory standards... presents information logically and concisely, both verbally and in writing, including writing reports with clarity...

Provide qa support for technology transfer and improvement of existing manufacturing processes... responsible for product release, ensuring products meet cgmp, janssen...

Calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities...

Experience and skills: required: excellent understanding and application of global regulatory (cgmp/ich/fda/ema) guidelines... for this project we want to strengthen...

Communication with regulatory authorities... plan, create, analise and/or review medical devices (cep, cer, pep, per)prepare professional opinions and regulatory...

Participate in the qa annual program of self-inspections... collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the...

Conocimientos específicos: gmps / regulatory affairs en eu, fda, mercado no regulado... desde mabxience, compañía especializada en el desarrollo y fabricación de...

Calling all senior qa managers, this is a unique opportunity to make real change within the medical device field... 8 years within quality preferably in the medical...

Experience: • practical experience of at least 3 years in the pharmaceutical industry, a majority of which has been gained in a qa environment... •  control of narcotics/controlled...

Coordinate with sap (it) improvements proposed by and for the qa department... review and approve documents and sign the certificates of analysis of all batches...

Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to...

Global responsibilityassure compliance of gmp, regulatory and internal standards according to quality policies and applicable requirements within the organization...

Promotes standardization of auditing approach within qa... participates in the development\/enhancement of qa procedures, guidance documents and audit tools to ensure...

Participating in the selection of the qa team members... the role is responsible to support and facilitate the regulatory affairs activities to ensure that products...

Follows up on regulatory approval status of the countries involved and assesses impact on the transfer plan... leads stock-build planning if required, based on transfer...

\u extensive knowledge of pharmaceutical research and development processes and regulatory environments... the qa function is responsible for driving compliance...

• extensive knowledge of pharmaceutical/clinical research and development processes and regulatory environments... perform quality event management within qa-capa...

Partner with qa document control, qc, manufacturing, execution systems, plant logistics, validation/compliance, and regulatory affairs to ensure documentation/process...