Senior Validation Expert

Location: Haarlem, Noord-Holland  |  Sector: Pharmaceuticals  |  Start Date: 7/10/2024  |  Job ref: 53081

The company
This client focuses on diseases where the need for new medicines is high and the cost high. This multinational is known as one of world’s biggest generic drug manufacturers. In the Netherlands, the core focus areas are neurology and pulmonology and the marketing of products for rheumatological conditions.

Role description
As a Senior Validation Expert, you will bring extensive experience in validating and re-qualifying pharmaceutical equipment and systems. Your role will encompass project work, handling changes, and addressing CAPAs. You will be a key player in ensuring compliance with regulatory standards, optimizing operational efficiency, and maintaining product quality. You will be: 

  • Leading and supporting daily operations, ensuring smooth functioning and project success.
  • Advising, coaching, and guiding colleagues to achieve the best results.
  • Proactively identifying and implementing improvements across departments.
  • Working closely with Production & Warehouse, Technical Service, and Performance Excellence teams.
  • Inspiring colleagues and aligning different departmental interests.
  • Ensuring continuous improvement in OHS, environment, and sustainability through a management system approach.
  • Providing professional support for departments and projects including permit applications, RI&Es, HAZOP, incident investigation, and HSE plan assessment.
  • Maintaining excellent relationships with all relevant parties, particularly various competent authorities. 

Responsibilities 

  • Leading and executing Installation Qualification, Operational Qualification, and Performance Qualification activities.
  • Overseeing validation protocols and plans for equipment such as steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, and air flow visualization studies.
  • Documenting and notifying relevant parties of deviations, coordinate corrective actions, and ensure timely resolution.
  • Providing expertise on validation issues to project teams and stakeholders.
  • Collaborating with cross-functional teams to align validation activities with production schedules and quality standards.
  • Conducting risk assessments and impact analyses for validation activities, proposing appropriate mitigation strategies.
  • Drafting, reviewing, and evaluating validation data, deviations, and change controls for regulatory and internal compliance.
  • Ensuring adherence to Good Manufacturing Practice and Good Documentation Practice during all validation processes.
  • Assisting during internal and external inspections/audits, acting as a subject matter expert and effectively communicating with regulatory authorities.
  • Mentoring and training junior validation team members, sharing knowledge and best practices. 

Requirements 

  • Bachelor’s or higher degree in a relevant scientific or engineering discipline.
  • Minimum of 4-5 years in validation/Commissioning, Qualification, and Validation (CQV) within the pharmaceutical industry.
  • Knowledge and experience with GMP, including V-Model and Software Development Life Cycle (SDLC) methodologies.
  • Strong analytical, problem-solving, organizational, and project management abilities.
  • Attention to detail with a proactive, can-do attitude.
  • Excellent written and verbal communication skills for effective collaboration with multidisciplinary teams.
  • Proficiency in English is required; 

Other information 
Apply to our vacancy for more information. Looking forward to getting in touch!

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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

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