Job Description

Key Responsibilities:

• Serve as a Subject Matter Expert (SME) for Quality Control, Manufacturing, and other departments in the design, operation, and troubleshooting of analytical equipment.
• Lead and execute validation plans for analytical system updates and process improvements.
• Conduct and document Installation Qualifications (IQ), Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as required.
• Manage validation-related records such as Change Controls (CC), CAPAs, and Deviations using TrackWise.
• Develop documentation including User Requirement Specifications, Data Integrity Risk Assessments, and Audit Trail Risk Assessments.
• Review equipment manuals and develop comprehensive validation strategies.
• Oversee procurement of analytical equipment, ensuring specifications, quotations, budget alignment, and proper installation.
• Maintain ownership of analytical equipment throughout its lifecycle.
• Identify and resolve quality issues, engaging key stakeholders as needed.
• Participate in risk assessments and support commissioning/qualification document reviews and approvals.
• Perform other duties as assigned.

Required Skills and Qualifications:

• In-depth technical knowledge of Quality Control and manufacturing processes.
• Hands-on experience with Quality Systems (e.g., deviations, CAPAs, change controls) and TrackWise.
• Strong understanding of validation processes across equipment, cleaning, computer systems, and manufacturing.
• Proven ability to manage medium-to-large scale projects within defined timelines.
• Excellent organizational and planning skills with sound decision-making capabilities.
• Collaborative mindset with strong interpersonal skills and cross-departmental experience.
• Role model in GMP and safety compliance.
• Strong verbal and written communication skills.
• Proficient in MS Project, Word, Excel, and PowerPoint.

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