Pharmaceutical Quality Assurance Manager

2 weken geleden

Hoofddorp, Noord-Holland, Nederland Nordic Pharma Voltijd

About Nordic Pharma

Nordic Pharma is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma's expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Women's Health, Ophthalmology and Critical Care.

Nordic Pharma's values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working.

Job title: Pharmaceutical Quality Assurance Manager

Department: Quality and Tech Transfer

Reporting to: Sr Quality Manager

General job description

The main purpose of the Pharmaceutical Quality Assurance Manager is to complete the activities related to GMP/GDP and linked to the MAH QA responsibilities, under Global Quality & Tech Transfer Director supervision. Among your activities, you will oversee a portfolio of products representing 30% of the turnover of product requiring the supervision of 3 finish product manufacturers and 3 active ingredient suppliers. For this portfolio you will be responsible for the management of major pharmaceutical projects (technological transfers, new launches change in packaging) requiring analytical solution-oriented mindset, agility and running activities in parallel

Essential responsibilities and tasks:

  • Participate in maintenance of the implemented Quality Management System for all global products
  • Quality surveillance of contractors/partners involved in GxP activities
  • Follow-up on quality complaints, managed by the Quality Assurance Associate
  • Conduct the internal and external audits under GMP/GDP
  • Oversee the maintenance of the quality documentation, define/review the controlled documents, deliver quality trainings, and manage the EDMS
  • Ensure the follow up of all changes implemented to CMOs, with impact evaluation and project management (transfer, new manufacturers etc.)
  • Preparation and participation in the Competent Authorities' inspections (GxP)

Qualifications, experience, and skills required:

  • Scientific education (master's degree) or Pharmacist with specialization in quality assurance
  • The knowledge of Quality Control and batch release
  • Experience at QC laboratory and/or manufacturing site is necessary
  • Minimum 5 to 7 years of experience in the GMP/GDP quality pharmaceutical environment
  • Realization of external /internal audits as lead auditor
  • Fluent English (spoken and written)

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