Vacature GMP Compliance Manager

For our client in Utrecht we are looking for a GMP Compliance Manager. Our client is a international biotechnology company focused on research.

The GMP Compliance Manager has the following tasks:

" Provides QA support to GMP operations.
" Independently executes QA Operations in change control, document control, deviation resolution, CAPA, batch record review, and lot release.
" Issues and approves Certificates of Analysis and Certificates of Conformance.
" Reviews contract manufacturing organization (CMO) documents, SOPs, and batch records.
" Approves and closes deviations, document changes, CAPA's and change orders in compliance with SOPs and applicable regulatory requirements.
" Conducts root cause analysis and identify corrective/preventive actions, as appropriate.
" Plans, conducts and reports Quality Audits within GMP regulated areas both internally and externally.
" Reviews and revises current SOPs for QA operations as necessary.
" Evaluates and provides input into the development of Quality Systems.
" Provides GMP training to staff and contractors as needed.
" Establishes collaborative working relationships with other staff in Operations.
" Evaluates and directs the resolution of quality issues by developing effective interdepartmental and cross-functional partnerships.
" Identifies quality issues and communicate to manager as appropriate.
" Serves as the Quality representative on cross-functional and multi-site teams as required.

You are Pharmacist at minimal Master of Science (drs.) level. A advanced degree is preferred. You have a mimimum of 10 years experience in the (bio)pharmaceutical industry and a minimum of 5 years relevant experience in a Quality function (QC or QA). Experience in Manufacturing and Continuous Improvement programs within the biotechnology industry is a plus. You have a strong ability of problem solving, a strong understanding of cGMPs and excellent interpersonal skills and the ability to prioritize multiple tasks. You have prior experience in Change Control, Deviations, CAPA's and have a good understanding of Quality Systems and regulatory expectations. Furthermore you have knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing. You are willing to travel up to 25% of the time.

A challenging position in an international company. Both the primary and the secondary conditions of this position are excellent. For more information about this vacancy, please contact Simon Hanyan on 0718906000. We are glad to answer your questions.