- ASAP - QA 6 months project
- Biotech company
About Our Client
One of the largest biotech companies in Switzerland.
- 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