Please refer to JobSuchmaschine in your application
Adsano® is an international service provider offering many years of experience in the areas of qualification, validation, calibration and quality management in the pharmaceutical industry.
The hiring and placement of qualified technical and managerial staff completes the range of our services.
For a permanent position within a renowned pharmaceutical company in the Basel area we are looking for an experiencedValidation Expert
Establish, write, and maintain key elements of the Validation Master Plan for process and cleaning validation
Support Process Validation Lead in executing and maintaining the VMP activities (process and cleaning validation)
Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site
Adhere to established procedures & templates for validation documentation and validation master plan
Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes
Review and interpret risk assessments for validation. Translate the critical process parameters and the process control strategy into a focused validation plan for process validation
Review and author validation protocols and reports. Support the execution at the shop floor
Collect and provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation
Understand potential risk areas/shortfalls and make sure that the assigned validation area is always inspection ready
Validation Master Plan (VMP) elements that are assigned are completed and up to date
Meet established validation and revalidation milestones according to approved validation plans
No critical/major observations during audits/inspections, products maintained in constant state of validation
Launches implemented on schedule and on target without validation related issues. Deliver validation data that meet the target schedule and quality to support the required registration documentation
Validation approach meets internal QM requirements, health authority and industry standards
Training curriculum up-to-date
Education (minimum/desirable): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology
Languages: English fluent in speaking and writing. French is an asset
Experience/Professional requirement (for recruitment purpose)
5 years experience in manufacturing/ manufacturing science and technology/technical development/Quality
Thorough understanding of manufacturing processes and related process equipment
Strong working knowledge of quality systems and regulatory requirements across multiple health authorities
3 - 5 years experience in executing process validation
Expert in reviewing and writing technical reports
Proven experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
Fundamental understanding of standard pharmaceutical analytical testing.
We are offering you an interesting and varied position in an international pharmaceutical environment. Are you interested? We are now taking applications and, of course, guarantee absolute discretion. We look forward to meeting you!
Adsano Engineering AG