104 days ago on adsano.ch

Validation Expert

Adsano Engineering AG

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 Please refer to JobSuchmaschine in your application

Validation Expert

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 experienced

Validation Expert

Job Profile

  • 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

  Candidate Profile

  • 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

Marc Bürgi
Kirchgasse 17
4450 Sissach
061 226 44 82online bewerben