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Job Details

Quality Manager Drug Product

Company: CTC Resourcing Solutions
Location:
Reference: 895750-P
Closing Date: 19 May 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Our client, a Swiss biopharmaceutical company, is looking for a Quality Manager Drug Product for a permanent role based in the Basel area, Switzerland. The ideal candidate should have previous experience in quality assurance of drug product and excellent knowledge of GMPs and regulatory environments in the pharmaceutical industry or CRO. Please contact us directly for more details at recruitment@ctcresourcing.com

Requirements:

Main Responsibilities:

 

  • Provide GMP/GDP quality assurance expertise during development and later during commercialization of company’s products
  • Assist in the performance of GMP onsite audits at CMOs
  • Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
  • Write, review, and/or approve internal SOP and other GMP/GDP related documentation
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards
  • Establish a quality risk management approach in projects based on six sigma concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
  • Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
  • Notify management of potential quality and regulatory issues
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed
  • Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.

Qualifications and Experience:

  • Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical/science university degree
  • Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
  • In addition, minimum of 3 years’ experience in quality assurance of drug product
  • Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards
  • Strong interpersonal and influencing skills
  • Excellent verbal and written communication skills in English
  • Ability to manage multiple tasks with competing priorities
  • Entrepreneurial mind set combined with cost consciousness
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Quality Manager Drug Product

Contact Information:

Address:  Head Office
Münchensteinerstrasse 41
4052 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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