Posted on Dec 10, 2018 by RM IT Professional Resources AG
Validation Expert with profound manufacturing processes knowledge wanted for our Aargau based client in the pharmaceutical sector.
- Bachelor degree in Chemistry, Pharmacy, Pharmaceutical Technology or Chemical Engineering
- Several years' experience of working in Manufacturing/Manufacturing Science as well as Technology/Technical Development and Quality
- In-depth knowledge of manufacturing processes and related process equipment along with practical knowledge in quality systems and regulatory requirements across multiple health authorities
- Proven project management experience in a cross-functional environment along with executing process validation
- Expertise in reviewing and writing technical reports and familiarity with standard pharmaceutical analytical testing
- Languages: fluent English and German both written and spoken
- Providing support in writing and maintaining Validation Master Plan for process, cleaning and packaging validation
- Assisting in the strategy for continued process verification (CPV) and annual monitoring batches along with contribution to risk assessments for CPV
- Conducting, facilitating, elaborating and authorising risk assessments for validation in collaboration with the site validation team (PU, QC, QA) and external functions
- Authorising and reviewing process, packaging or cleaning validation protocols and contributing or writing, reviewing as well revising any SOPs related to validation activities
- Establishing local procedures and templates for respective validation processes, documentation and Validation Master Plan as well as creating assessments on component criticality as well as ensuring that all validation activities are in line with cGMP
- Maintaining responsible activities and projects in an inspection ready status for internal or external audits
Location: Aargau, Switzerland
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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