Sr Research Analyst 1

Job Purpose

To oversee the end-to-end procurement, lifecycle management, and validation of GxP-regulated equipment and software. This role ensures total compliance with cGMP, 21 CFR Part 11, and QMS standards while maintaining a safe, environmentally compliant operational environment.

Responsibilities

• Supporting the team for procuring equipment & preparing the related documents like User request specification (URS), CAPEX approval, technical comparison sheet and procuring the equipment/software.
• Equipment life cycle management along with corresponding teams.
• QMS (Ample logic) activities related to Equipment/software/system /CSV (new and legacy equipment) before & after the installation and Maintenance.
• Supporting the team for preparing and updating the SOPs related to Equipment/software spare parts and column system as cGMP.
• Guiding the team for procuring (requesting & Approval) and maintaining columns with the respecting documents. And maintaining the columns stock & Equipment spares in SAP.
• Leading the team in Computer system validation (CSV) for new procuring GxP equipment/software and establishing the same CSV for legacy equipment. Computer system validation as per 21 CFR part 11 for legacy GxP equipment/software implementation by phase wise.
• Supporting the team for arranging and maintaining the Archive room activities.
• Preform any other work assigned by Manager and support colleagues whenever necessary.
• Execute daily operations in compliance with EMS and HSE standards, using appropriate PPE and safe practices.
• Identify, reduce, and prevent environmental impacts and operational risks.
• Contribute to EHS activities, audits, and continual improvement initiatives.
  
  

• Bachelor’s degree in pharmacy/ chemistry/chemical engineer or related Sciences. With minimum 5 years’ experience in the Product Development/Research and Development from a Pharmaceutical field.
• Should have handled similar role for a better fitment of this role.
• Proven experience of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
• Advance Knowledge of statistics, and their applications.
• Strong Knowledge in international guidelines such as ICH, USP, EP, BP and WHO. Scientific approaches in method development and method validation. Different instrumentation and instruments trouble shooting. And analytical trouble shooting.