Our client is a global leader in the production of generics and biopharmaceuticals. The aim is to develop new and innovative treatments and to offer patients more affordable solutions in different therapeutic areas.
They have a complex global supply chain able to reach more than 60 counties.
In the role of a Senior Validation Consultant, your responsibilities will include crafting and overseeing the implementation of validation protocols and plans for pharmaceutical manufacturing equipment validations and re-qualifications. You’ll also be tasked with ensuring the accurate and timely completion of the annual re-qualification plan.
– Document, notify, and coordinate corrective actions in the event of deviations, ensuring proper resolution and closure
– Provide valuable technical expertise and guidance on validation-related matters to project teams and stakeholders, enhancing overall project quality
– Collaborate with cross-functional teams to ensure that validation activities align with production schedules, project timelines, and quality standards
– Conduct risk assessments and impact analyses for validation activities
– Draft, review, and assess validation data, deviations, and change controls to meet regulatory requirements and internal quality standards
– Bachelor’s degree or higher in a relevant scientific or engineering discipline
– Minimum of 10 years of experience in pharmaceutical industry validation of various equipment
– In-depth knowledge and experience with Good Manufacturing Practice (GMP) standards
– Strong analytical, problem-solving, organizational, and project management skills
– Dedicated team player with keen attention to detail and a proactive “can-do” attitude
– Excellent written and verbal communication skills in English
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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