משרות תוצאות חיפוש מתאימות לבקשתך:

The opportunity
As a Senior Validation Expert you will play a pivotal role in upholding the highest standards of quality and regulatory compliance within the pharmaceutical industry.

Your expertise in equipment/system validation and re-qualification, coupled with your in-depth knowledge of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies, and validation practices, will be instrumental in ensuring the consistent production of safe and effective medicines.

You will collaborate with cross-functional teams to develop and implement comprehensive validation plans, ensuring adherence to regulatory requirements and industry standards. You will also play a key role in managing project work, changes, CAPAs, and deviations, ensuring timely resolution and maintaining operational efficiency.

You will also have the opportunity to mentor and train junior validation team members, sharing your knowledge and experience to foster a culture of excellence within the organization.
How you’ll spend your day
Lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Support execution of validation protocols/plans for Validations/Re-qualifications of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies
In case of deviations; Document, notify & co-ordinate for corrective action, and close out.
Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
Collaborate with cross-functional teams to ensure validation activities align with production schedules, project timelines and quality expectations.
Conduct risk assessments and impact analyses related to validation activities and propose appropriate mitigation strategies.
Draft, review and assess validation data, deviations, and change controls to ensure compliance with regulatory requirements and Teva internal quality standards.
Ensure adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
Support during internal/external inspections/Audits in addition to representing relevant topics as an SME & having solid knowledge to communicate with authorities.
Mentor and provide training to junior validation team members, sharing knowledge and best practices.