Job Title:  Senior Manager - CDMO IT

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

• Lead the planning, implementation of IT infrastructure and network for the process and analytical functions of CDMO.
• To oversee and support during installation and implementation of IT systems, manufacturing equipment, Enterprise applications like SAP ERP, Document Management Systems, Testing and Training Systems and Quality and Manufacturing systems like SCADA, PLCs, MES (eBMR, L2 Integration), LIMS and other highly complex automated systems
• Support the technical team to ensure that process data is available via OPC/similar interfaces to centralised data base systems (e.,g Aveva PI).
• Develop, Implement and ensure Consistent & Documented compliance to required CSV frameworks, policies, and procedures in alignment with pharmaceutical industry regulations (GxP, GAMP5, Safety Health & Environmental (SHE), Data Integrity (DI), Quality and Best Practice requirements etc.).
• Act as a system administrator for IT system and be primary SPOC for user management access functions.
• Act as a custodian of electronic data and responsible for data backup and restoration.
• Assist vendor for trouble shooting related to IT systems.
•  Understand the QMS requirements and Collaborate with cross-functional teams within Company to ensure quality standards for software development, infrastructure management, and data integrity.
• To provide regular, accurate and timely reporting of progress to the Site leadership, CQA, IT-QA, Project sponsors and Stakeholders.
• Ensure that Computer systems, processes, and documentation adhere to regulatory requirements and internal quality standards, and be primary presenter during audits. Collaborate with Supplier, QA & ITQA teams to address audit findings and implement corrective and preventive actions (CAPAs).
• Assess, Evaluate, Monitor and carry out periodic reviews of Computer systems for validation, user access management, data integrity, and compliance with relevant regulations.
• Maintain and update IT compliance documentation, including standard operating procedures (SOPs) and validation documents and follow periodic Training and Evaluation plan for the team to ensure that site is ready for audit.
• To carry out Gap assessment/ Periodic review of GxP Computerized Equipment to meet regulatory requirements.
• To carry out the assessment of various IT system vendors including providers for cloud services.
• To check compliance of GxP application servers’ security & data back-up and restoration procedure. Initiate/ Review QMS elements related to computerized system.
• Creating sponsor specific firewalls for all aspects of data integrity and security

KEY DELIVERABLES

• Responsible for preparation and review of documentation related to qualification of LIMS, ELN and any other digital platforms.
• Responsible for CSV, ELN, LIMS, EBMR and related software troubleshooting.
• Person should be subject matter expert for all the digital platforms.
• Ensuring the quality and suitability of IT systems installed in the CDMO facility for maintaining integrity and safety.
• A strong  understanding of equipment used in biopharmaceutical manufacturing and testing as relates to IT aspects.
• Strong Cross functional communication skills is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.

ALLIED RESPONSIBILITIES

• Manage multiple projects and reporting
• Good understanding of manufacturing Instument & validaiton 

EXPERIENCE

• 8 to 12 years of relevant work experience in CSV and digitization in pharmaceutical industry
• Preference will be for personnel having prior experience in Information Technology, CSV digital platforms and its compliance.
• Work experience on digital compliance in the Pharmaceutical / Bio-pharmaceutical will be strongly preferred

EDUCATIONAL QUALIFICATION

• Bachelor/Master’s in Computer Applications/Information Technology