Remote Pharma Process Validation Analyst

Placements24; Puebla de Zaragoza; Hybrid; MXN 420,000 - 620,000; Full time

Job summary

Placements24 is seeking a Process Validation Analyst to join its quality assurance team. This remote role focuses on developing, executing, and documenting validation protocols for manufacturing processes, equipment, and analytical methods to ensure regulatory compliance.

The ideal candidate has a solid understanding of validation principles, cGMP guidelines, and experience in a regulated pharmaceutical environment. You will contribute to product quality and patient safety from a remote setting.

Qualifications

• Bachelor's degree in Pharmacy, Chemical Engineering, Biotechnology, or a related scientific discipline.
• Minimum of 3 years of experience in process validation within the pharmaceutical industry.
• Solid understanding of IQ, OQ, PQ and statistical analysis.
• Knowledge of cGMP regulations applicable to pharmaceutical manufacturing.
• Experience with sterile, oral dosage forms, or biologics processes, and strong documentation skills.

Responsibilities

• Develop validation master plans, protocols, and reports for manufacturing processes, cleaning, equipment, and analytical methods.
• Execute IQ/OQ/PQ validation protocols ensuring data integrity and accuracy.
• Analyze validation data, compare results to criteria, and write comprehensive reports.
• Identify and investigate deviations during validation activities.
• Collaborate with manufacturing, engineering, quality control, and QA to ensure successful validation.
• Ensure compliance with cGMP, FDA/EMA/COFEPRIS and internal SOPs.
• Maintain validation documentation and records in an organized manner.
• Participate in regulatory inspections and internal audits related to validation.
• Stay updated on industry practices and regulatory expectations for process validation.
• Provide training and guidance on validation requirements and procedures.

Skills

IQ/OQ/PQ

GxP knowledge

Data analysis

Documentation

Education

Bachelor's in Pharmacy

Chemical Engineering

Biotechnology

Tools

Validation software

Microsoft Office

Job description

Placements24 is seeking a Process Validation Analyst to join its quality assurance team. This remote role focuses on developing, executing, and documenting validation protocols for manufacturing processes, equipment, and analytical methods to ensure regulatory compliance.

The ideal candidate has a solid understanding of validation principles, cGMP guidelines, and experience in a regulated pharmaceutical environment. You will contribute to product quality and patient safety from a remote setting.