Assistant Manager - CDMO CSV

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly.

Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

JOB DETAILS

• Develop and execute validation plans (VMP), user requirements (URS), functional specifications (FS), and test protocols (IQ/OQ/PQ).

• Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulations.

• Perform risk assessments and impact analyses for computerized systems.

• Maintain validation documentation and traceability matrices.

• Collaborate with QA, IT, and business units to ensure systems meet regulatory and business needs.

• Manage change control processes and revalidation activities.

• Support audits and inspections by regulatory authorities.

KEY DELIVERABLES