Associate Validation Analyst II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Responsibilities

• Participates as a member of project teams, contributing to direction on future enhancements to the system, reviewing change requests and ensuring effective communication and accuracy in testing.
• Provides validation support for new releases and modifications to applications throughout the software development process (new equipment qualifications, software upgrades, retirements etc.).
• Drafts Change Controls, VDA, IQ, OQ documents through to pre-approval on validated GMP standalone hardware and software systems per SOP.
• Manages Vendor installs on validated GMP standalone hardware and software systems per SOP.
• Completes IQ, OQ documents for validated GMP standalone hardware and software systems according to SOP.
• Provides ongoing business support to users during the implementation and continued use of validated platforms, ensuring that appropriate training, support, and maintenance is provided.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Entry level to 2 years of experience in Validation Analyst work with GMP exposure to working on standalone hardware and software systems an advantage.
• Experience of leading vendor activities on site.
• Demonstrates strong analytical skills and attention to detail.
• Demonstrable ability to work closely in a team-oriented environment.
• Good communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint & Project) and other data analysis tools.
• Ability to technically adhere to deadlines and lead multiple tasks concurrently.

Hybrid role - First two months to be on-site 80% of time to complete required trainings, there after minimum of 3 days a week required.