Description
A multinational pharmaceutical company is urgently looking for a Senior QA Specialist to be part of the QA-IPT Pharma-Outbound department to ensure all activities for the related IPT are in compliance with cGMP, regulatory and legal requirements and products released to the market are in line with regulatory filings.Your primary purpose within this position will be to support regional department with regard to production quality related topics and issues (corrective and preventive actions).:
Responsibilities
-Review investment projects from Q point of view and support departments by acting as an expert or project lead in Q, compliance and continuous improvement projects.
-Check and authorize within scope change, qualification and validation documents, CAPA`s and SOP`s.
-Determine and decide upon quality and GMP requirements for new products
-Monitor activities within scope concerning compliance and take necessary action.
-Supportive role during external audits.
-Advise the departments within scope and ensure implementation of quality related knowledge, procedures and guidelines.
-Ensure master batch records are in compliance with guidelines.
-Responsible for supplier management for one or more suppliers and approve new suppliers.
-Support and manage incidents investigations, including supplier`s involvement Analyze quality performance.
-Responsible for the realisation of our corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
Job requirements
-At least Bsc. in life sciences, biology, pharmacy or chemistry
-5 or more years experience in a GMP/Quality related role within Pharmacy (or closely related)
-Experience within a packaging environment.
-Experience with continuous improvement and lean thinking is an asset.
-Quality and compliance driven.
-Good interpersonal skills.
-Ongoing focus on identification and realization of improvement potential.
-Good written and oral communication skills (both in English and Dutch)
Please do apply for more information.