Senior Validation Expert

Location: Haarlem, Noord-Holland  |  Sector: Pharmaceuticals  |  Start Date: 1/4/2024  |  Job ref: 52097

the company
This company is a global leader in the development and production of affordable generic medicines and innovative specialty pharmaceuticals. With a rich history spanning over a century, this company is dedicated to enhancing health and improving the lives of patients worldwide. By leveraging cutting-edge research, advanced technology, and a commitment to quality, this company delivers a wide range of high-quality generic and specialty medications across various therapeutic areas.

Role Description
As a Validation expert at this company, you will be validating and re-qualifying equipment and systems, including project work/changes/CAPAS. A crucial part within this role is making sure that the regulatory requirements are followed, and the industry standards are met while finding ways to improve operational efficiency and product quality.  

Responsibilities
-Leading and taking part in equipment validation activities.
-Assist in implementing validation procedures/plans for initial validations and re-certifications of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies.
-If there are any differences or inconsistencies; record, inform, coordinate corrective measures, and finalize
-Sharing technical knowledge and guidance when validation-related issues appear
– Work together with diverse teams to ensure that validation tasks match production timelines, project schedules, and quality standards
-Perform evaluations of potential risks and analyze their effects on validation tasks, suggesting suitable ways to minimize these risks
-Create, examine, and evaluate validation information, variations, and modification management to guarantee adherence to both regulatory standards and the internal quality benchmarks of the company
Guarantee compliance with GMP and GDP while carrying out the validation tasks
-Guide and offer instruction to junior members of the validation team, sharing expertise and the most effective methods

Requirements
– Experience with steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies & validation within the pharmaceutical industry
-Bachelor or Higher degree in a relevant scientific or engineering field
-Minimum 4 years of experience in validation/CQV within the pharmaceutical industry
-Knowledge or experience with GMP including V-model & SDLC methodologies
-Proficient in analytical thinking, problem-solving, organization, and project management
-Collaborative team player with attention to detail and a proactive mindset

Other information
Apply to our vacancy for more information. looking forward to hearing from you!

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About us

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

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.