Sr. Validation Specialist
Offer
- a challenging job within a global pharmaceutical company
- an operational role in an international environment
- a temporary contract till 19 May 2025
Position
As a Sr Validation Specialist, you are a highly experienced consultant with extensive skills in the validation and requalification of equipment/systems, encompassing project work, changes, and CAPAs. Additionally, you possess knowledge of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/airflow visualization studies, and validation within the pharmaceutical industry. You play a crucial role in ensuring compliance with regulatory requirements and industry standards while optimizing operational efficiency and product quality.
You lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Furthermore, you provide support in executing validation protocols/plans for validations/requalification’s of various equipment and systems.
In case of deviations, you document, report, and coordinate corrective actions to ensure closure. You offer technical expertise and guidance on validation-related matters to project teams and stakeholders, collaborating with multidisciplinary teams to align validation activities with production schedules, project timelines, and quality expectations.
You conduct risk and impact analyses related to validation activities, you propose appropriate mitigation strategies. Additionally, you oversee the drafting, reviewing, and assessing of validation data, deviations, and change controls to ensure compliance with regulatory requirements and internal quality standards.
During validation activities, you uphold adherence to GMP and GDP. Providing support during internal/external inspections/audits, you represent relevant topics as a Subject Matter Expert (SME) and communicate effectively with authorities. As a mentor, you offer training to junior team members in validation, sharing knowledge and best practices.
Profile
- bachelor’s or higher degree in a relevant scientific or engineering discipline;
- minimum of 5 years of experience in validation/CQV within the pharmaceutical industry;
- in-depth knowledge, and experience in GMP including V-Model & SDLC methodologies;
- strong analytical, problem-solving, organizational and project management skills;
- team player with attention to detail and strong can-do mentality;
- excellent written and verbal communication skills, including the ability to effectively collaborate with multidisciplinary teams;
- ability to work independently with minimal guidance;
- English language sufficient, Dutch would be a bonus.
Organisation
Our client is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Their employees are at the core of their success, with colleagues in over 80 countries, delivering the world’s largest medicine cabinet to 200 million people every day. They offer a unique, diverse portfolio of products and solutions for patients and they have built a promising pipeline centred around their core therapeutic areas. They are continually developing patient-centric solutions and significantly growing both their generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how they improve health and enable people to live better, healthier lives.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/24-154-DD, to Annerien Peters: info@derksenderks.nl. For more information, please call, text or WhatsApp Annerien via +31 (0)6 45403933.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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