Assistant Manager - CDMO CSV

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.

• 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.

1. Create Validation Master Plan (VMP) detailing A high-level document outlining the overall strategy, scope, and approach for validating computerized systems across the organization.
2. User Requirements Specification (URS) by Clearly defined functional and regulatory requirements that the system must meet.
3. Risk Assessment: Identification and evaluation of potential risks to product quality, data integrity, and patient safety, often using tools like FMEA.
4. Functional Design Specifications (FS/DS) - Detailed documentation of how the system will meet the URS, including technical and functional design.
5. Traceability Matrix - A document mapping each requirement to its corresponding test case, ensuring full coverage and compliance.
6. Validation Protocols -
- IQ (Installation Qualification) - Verifies correct installation of the system.
- OQ (Operational Qualification) - Confirms the system operates as intended under all anticipated conditions.
- PQ (Performance Qualification) - Demonstrates the system performs effectively and reproducibly in the production environment.
7. Test Scripts and Execution Reports - Step-by-step test cases with expected results, and documentation of actual outcomes and deviations.
8. Change Control Documentation - Records of any changes made to the system post-validation, including impact assessments and revalidation activities.
9. Validation Summary Report (VSR) - A comprehensive report summarizing the validation process, results, deviations, and conclusions.
10. Audit Trail Review Data Integrity Checks - Ensuring systems maintain secure, accurate, and complete records in compliance with 21 CFR Part 11 and Annex 11. Conduct periodic review of QMS records
12. Schedule Quarterly review meeting with all the stakeholders

• Ensures data integrity, patient safety, and product quality.
• Supports regulatory compliance and reduces risk of non-compliance.
• Enhances operational efficiency and reduces manual errors.
• Strong understanding of regulatory requirements (FDA, EMA, MHRA)
• Familiarity with validation tools and documentation practices.
• Excellent analytical, documentation, and communication skills.

3-7 years of experience in CSV within the pharmaceutical or life sciences industry

Bachelors of Engineering / Science.

Master degree will be an add on advantage