Deputy Manager - Computerized Systems Validation (CSV)

Role & responsibilities

The Deputy Manager - CSV will be responsible for overseeing the validation of computerized systems in manufacturing and laboratory environments, ensuring compliance with regulatory standards and best practices. This role requires strong technical knowledge, attention to detail, and effective communication skills to collaborate with various stakeholders.

Desired Candidate Profile :

The candidate must have a minimum of 5 years of experience in the pharmaceutical industry, with at least 5 years focused on end-to-end Computerized Systems Validation (CSV) for manufacturing and laboratory equipment.

• Detail-oriented, with primary responsibilities including authoring in-house CSV documentation and reviewing vendor-provided documents.
• Experience with software development lifecycle (SDLC) processes, models, and standards relevant to the pharmaceutical industry.
• Ability to prepare and review end-to-end CSV lifecycle deliverables for manufacturing (HMI, PLC, DCS) and laboratory equipment (e.g., GC-Empower, KF Titrino-Tiamo, UV & FTIR systems, Stability Chambers - ICDAS).
• Good exposure and hands-on experience with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines and compliance requirements.
• Proven experience in independently leading validation projects and ensuring compliance in system maintenance activities, including data backup and restoration, user access management, audit trail review, and periodic reviews.
• Strong oral and written communication skills to facilitate collaboration among site stakeholders.
• Involvement in Quality Management System (QMS) activities related to computerized systems and engineering as applicable.
• Knowledge and experience in the validation of Distributed Control Systems (DCS) and Laboratory Information Management Systems (LIMS).
• Familiarity with preparing risk management processes throughout the lifecycle of computerized systems.
• Commitment to complying with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, and ensuring the use of Personal Protective Equipment (PPE) where applicable.

Preferred Skills:

• Strong analytical and problem-solving capabilities.
• Ability to manage multiple projects in a fast-paced environment.
• Familiarity with continuous improvement initiatives related to computerized systems.

Work Location :

Piramal Pharma Limited ,Unit 3 , Digwal Village, Kohir Mandal, Dist. - Sangareddy, Telangana