Telugu Technical Writer Job

Hi Connections,

Smart Edge’s Client is looking for an individual to help with their Senior Lab Instruments Software Validation Analyst / Technical Writers _Contract _ Brussels, Belgium

Job Details:

Position: Senior Lab Instruments Software Validation Analyst / Technical Writers Location: Brussels, Belgium Job type: Contract

Job Description:

We are seeking an experienced Lab Instruments Software Validation Analyst with 10+ years of proven expertise in the clinical research industry, including a minimum of 5+ years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials. The ideal candidate will have in-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), cGMP, and regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11, along with strong leadership and cross-functional collaboration skills.   Validation Planning & Execution Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software. Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards. Documentation & Compliance Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications. Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies. Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented. 10+ years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry. 5+ years of hands-on expertise in the following skill areas: Analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems). Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation. Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5. Risk assessment, root cause analysis, and CAPA management. Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessment Documents, Traceability Matrices, Validation Summary Reports). Bachelor’s or master’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline. Preferred certifications: Computer System Validation (CSV), GAMP 5 Practitioner, or Quality/Regulatory Compliance credentials.

If this sounds like a role, you would be interested in or you know someone in this field.

Connect with me or email me at renuka.g@smartedgesolutions.co.uk

Alternatively, you can call me on Tel: +44(0) 2030513657