Assistant Manager

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

Developing validation documentation for CRO and CDMO for all the computerized systems applications used in GCP, GLP, GMP environments.

KEY DELIVERABLES

•    Lead the planning & implementation of Computer System Validation (CSV) activities across all Lambda verticals. 
•    To Prepare and implement computerized system validation (CSV) procedure in coordination with stakeholder of all Early Phase, late Phase, Development labs and cGMP facility
•    Support the technical team to ensure that process data is available for issue resolving the process
•    To carry out Gap assessment/ Periodic review of GxP Computerized Equipment to meet regulatory requirements.
•    To carry out regular internal audit of various GxP computerized.
•    To carry out the assessment of various IT system vendors including providers for cloud services.
•    Provide Computer system validation and documentation support during regulatory inspections.
•    Test script writing and preparation validation plan, CS and other validation documents
•    Review the validation and qualification document as per the GAMP requirements and provide the recommendation  
•    To check compliance of GxP application servers’ security & data back-up and restoration procedure. Initiate/ Review QMS elements related to computerized system.
•    To Prepare/ review IT compliance SOPs where scope is applicable
•    Response on the internal audit queries.

ALLIED RESPONSIBILITIES

EXPERIENCE

▪ Manages, track, report the day-to-day progress for CSV activities

▪ Coordinates the training programs for new staff and identifies training needs for current staff.
▪ Conduct and participate in cross functional meetings with different stake holders.

EDUCATIONAL QUALIFICATION

Bachelor's degree in Sciences / Engineering or Business Administration required. Minimum 6-8 yrs related experience required preferably in CRO/service industry.

COMPETENCIES