We are looking a qualified professional for a position as a Validation Expert. As Subject matter expert for validation processes you guarantee (new) equipment is and stays validated and qualified.
Job Description:
We are looking for an experienced Validation Officer to specialize in the validation and (re-)qualification of Equipment. This includes Project work, Change control, and CAPA's. In this position you will focus on steam sterilizers / autoclaves, smoke / air flow visualization studies, and validation. You will play a crucial role in ensuring compliance with regulatory requirements and industry standards, with a focus on optimizing operational efficiency and product quality.
Responsibilities:
- Lead and actively participate in equipment qualification activities, encompassing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Execute validation protocols/plans for validations/qualifications of equipment.
- Document, notify, and coordinate corrective actions for deviations, ensuring timely closure.
- Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
- Collaborate with cross-functional teams to align validation activities with production schedules, project timelines, and quality expectations.
- Conduct risk assessments and impact analyses related to validation activities, proposing suitable mitigation strategies.
- Draft, review, and assess validation data, deviations, and change controls, ensuring compliance with regulatory requirements and internal quality standards.
- Uphold Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
- Provide support during internal/external inspections/audits and act as an SME while effectively communicating with authorities.
- Mentor and deliver training to junior validation team members, sharing knowledge and best practices.
Profile:
- Bachelor's or higher degree in a relevant scientific or engineering discipline.
- A minimum of 4~5 years of experience in validation/CQV within the pharmaceutical industry, with knowledge of GMP and including V-Model & SDLC methodologies.
- Strong analytical, problem-solving, organizational, and project management skills.
- Team player with attention to detail and a strong can-do mentality.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with multidisciplinary teams.
Benefits and practical information:
- Salary range: 3200-4900.
- Standard business hours: Full-time position
- Contract type: Temporary position, first contract through Oxford
- Region: Haarlem
