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Job Details

Senior Specialist, Quality Assurance

Company: Edelway Switzerland AG
Location: Basel area
Reference: SJ-01
Closing Date: 17 Aug 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Edelway is a pan-European Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Basel Area, Switzerland is currently looking for experienced Senior Specialist, Quality Assurance.

Requirements:

Key Responsibilities:

  • Responsible for the Quality System Improvement Program implementation including working on deployment team to assess gaps, implementation strategy, implementation execution and update of site documentation/processes as needed. At times, the incumbent may be a primary SME on changes that require them to train a cross-functional team across the site. The primary objective of this role is installation of QSIP deliverables on-time, as intended by the Divisional leads, and in a sustainable way to deliver an effective and efficient Quality Management System. This role will also have critical ties to Quality Council and the existing QMS program.
  • Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Acts as a resource for colleagues with less experience within own discipline. May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
  • Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. Explains difficult issues and works to build alignment around a complex situation. Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities.

Primary activities, but not limited to:

  • Review and approval of IQ/OQ documents.
  • Review and approval of System Development Life Cycle documention (SDLC).
  • Provides guidance on automation change controls.
  • Review and approval of automation change controls.
  • Provides information for regulatory inspections as requested.
  • Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
  • Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.
  • Individual may have the opportunity to support other areas within Quality Assurance organization, including: Change Control, SOP and Batch Record Management, Audits and Inspections,Deviation Management, Annual Product Reviews, Vendor Management, Inspection Management, QMS / Quality Council Management, Risk Management, Market Actions

Qualifications:

  • Bachelors degree. Degree in life science, scientific discipline or engineering preferred OR
  • M.S. degree in life science, scientific discipline or engineering.

Required Experience and Skills:

  • For candidates with a Bachelors degree, a minimum of 3 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
  • For candidates with a Masters degree, a minimum of 2 years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

Preferred Experience and Skills:

  • Progressive and demonstrated Quality decision making responsibility.
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
  • Demonstrated self starter with capability to develop innovative solutions to challenges.
  • Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
  • Strong written and verbal communication skills.
  • In-depth working knowledge and application of GMPs/GLPs.
  • Proven ability to manage multiple projects simultaneously.
  • Experience in pharmaceutical laboratory operations or related environment.

 

If this sounds like your next challenge please send us your CV at pharma@edelway.com

Apply for this job: Senior Specialist, Quality Assurance

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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