Validation Expert NOVJP00028432 (m/f)

REFERENCE NUMBER:

393053/29

MY DUTIES:

-Support writing and maintaining Validation Master Plan for process, cleaning and packaging validation
-Support the strategy for continued process verification (CPV) and annual monitoring batches that ensures all critical process parameters and quality attributes are defined after validation activities
-Contribute to risk assessments for CPV
-Set local procedures and templates for respective validation processes, documentation and validation master plan, create assessments on component criticality
-Maintain all responsible activities and projects in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities
-Lead, facilitate, elaborate and author risk assessments for validation together with the site validation team (PU, QC, QA ) and external functions (TRD, DRA)
-Ensure that all respective validation activities 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 launch projects as well as major or complex changes
-Author and review process, packaging or cleaning validation protocols (e.g. launches, transfers, weak point remediation) and related reports, propose and review MBRs and associated change controls
-Support the execution at the shop floor
-Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation
-Participate in transfers and launches, contribute to provide experimental data obtained during the validation activities which will be used to prepare the related registration documentation (e.g. P35 module)
-Support successful Handover, Submission and Launch with no delay of approval due to PAI or technical issues related to NTO
-Contribute or write, review and revise any SOPs related to validation activities, provide guidance to facility impact and component criticality assessments

MY QUALIFICATIONS:

-BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
-Fluency in English and in local language
-Profound 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
-Experience in executing process validation
-Expert in reviewing and writing technical reports
-Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
-Fundamental understanding of standard pharmaceutical analytical testing

MY BENEFITS:

-A very renowned company
-A city with a high quality of life that perfectly embraces both modern and traditional values
-A variety of cultural and recreational offers

PROJECT INFORMATION:

-As a modern company, our client manages to constantly develop further and break new ground

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.