Computerized System Validation

**HSO way of working** In fulfilling our roles, we are - Accountable for our own capabilities and development. - Focused on delivering results without excuses, and - Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively. We are looking for people who - See beyond self and are impact...

Job Title: Validation Professional - Software System CheckerAbout the Role:We are seeking an experienced Validation Contractor to join our team in the QC Laboratory. The successful candidate will be responsible for planning and executing validation activities associated with software system upgrades and decommissioning of legacy systems in a GMP-regulated...

Create, review or approve validation deliverables for GMP computerized systems including but not limited to: - User Requirements Specifications - Design Reviews - Criticality assessments - Validation protocols (IQ, OQ, PQ) - Incident/deviation reports related to test protocol execution - Provide validation guidance to cross-functional teams based on...

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...

Our organization specializes in emerging and frontier biology.We utilize cells as a final product or derive products from cells which often we use cells as the factory to derive our target product.Our team contributes to the overall site mission and objectives by ensuring Commissioning Qualification and Validation activities are planned and executed...

Job Title: CSV Validation SpecialistWe are seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong understanding of computerized system validation (CSV) principles and regulations, as well as experience working with cross-functional teams to ensure quality oversight in the life cycle procedure.Key...

**Responsibilities**: - Develop and execute Commissioning, Qualification, and Validation (CQV) protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facilities, equipment, and systems. - Collaborate with project teams to ensure compliance with regulatory standards (e.g., FDA, EMA, GMP). - Perform risk assessments, gap analysis, and prepare validation...

We are currently expanding our team within our Life Sciences Division team and are looking for a **Validation Engineer**to support projects on site with a client. The following are key responsibilities: - Review and approval of computer system validation protocols and reports. - Preparation and management of CSV deliverables for laboratory instruments and...

About UsAt No Deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape.We are a dynamic team of experts in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services. We are seeking individuals who are excited to contribute to impactful...

**Responsibilities**: - Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations. - Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations. - Promoting GMP awareness and a culture of continuous...