Quality Assurance

Baar Interim

added 11/10/2021

  • ASAP - QA 6 months project
  • Biotech company

About Our Client

One of the largest biotech companies in Switzerland.

Job Description

  • Quality Operations activities management with key/critical CMOs.
  • Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.
  • Develop knowledge of the manufacturing line at key/critical contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SME.
  • Collaborate actively with key/critical CMO to sustain without disruption the supply chain.
  • Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with expectations.
  • Participate to technology transfer, scale-up or improvements projects through validation and on-site presence.
  • Collect Key Process Indicators and Identify appropriate actions in collaboration with CMO up to successful implementation.
  • Contribute to Regulatory inspection, review of observations, responses and action plan follow-up.
  • Prepare and Manage Quality management Review, Annual Product Review performance and Quality agreement.
  • Support recall management.
  • Identify and drive improvements/updates of the GMP documentation related to QE activities.
  • Identify any compliance gap in processes and identify appropriate stakeholder to fix the issue.
  • Support local Quality system (change control, deviations, CAPAs, …) as required.
  • Ensure adherence to serialization and data integrity requirements.
  • Identify and timely communicate to the management any supply risk or risk of batch rejection.
  • Ability to successfully influence the peer level at CMOs.
  • Able to clearly communicate expectations to internal/external customers as well as management or peers.
  • Able to report status of ongoing activities to the manager/stakeholder, highlight any time constraints and propose action/time reallocation to the manager.
  • Develop and sustain an internal and external networking.
  • Leads matrix teams within a product program cross functionally or at global level. May also drive project initiatives.
  • Coach peers, coach other departments on quality regulations and tools, delegate and empower appropriately and build core skills and abilities.
  • May assist junior team members in the comprehension of team goals.

The Successful Applicant

  • A minimum of 5 years of experience in pharmaceutical or biotechnology industries.
  • Relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus).
  • Knowledge of medical device regulations and unit operations for manufacturing of either parenterals or pharmaceuticals, is a plus.
  • Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
  • Strong communication skills.
  • Ability to work in an international matrix environment.
  • Negotiation skills.
  • Ability to clearly articulate complex situation into resolution by providing path forward to the upper management.

What's on Offer

I am currently looking for immediately available candidates, based in Zug, Baar or in the region, with a valid work permit for Switzerland. Please note that this is a temporary job for 6 months.If you are currently looking for an opportunity, you match the qualifications and you would like to apply, please contact me directly.How: please apply directly to this job add or email me your cv or call me directly on 078 208 3960.I look forward to hearing from you soon! Thank you

Karin Souza
Quote job ref

Job summary

Contract Type
Consultant name
Karin Souza
Job Reference

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.