Analista De Validación De Procesos Farmacéuticos

Placements24; Puebla de Zaragoza; Hybride; MXN 420 000 - 620 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

IQ/OQ/PQ

GxP knowledge

Data analysis

Documentation

Formation

Bachelor's in Pharmacy

Chemical Engineering

Biotechnology

Outils

Validation software

Microsoft Office

Description du poste

About the Role

Our client, a recognized entity in the farmacéutico industry, is seeking a diligent and experienced Process Validation Analyst to join their quality assurance team. This position operates remotely, offering flexibility while ensuring critical validation activities are meticulously managed. You will be responsible for developing, executing, and documenting validation protocols for manufacturing processes, equipment, and analytical methods to ensure compliance with regulatory standards and internal quality systems. The ideal candidate possesses a strong understanding of validation principles, GMP regulations, and has experience within a regulated pharmaceutical environment. This is an excellent opportunity to contribute to the integrity and compliance of pharmaceutical manufacturing from a remote setting, impacting the delivery of safe and effective medicines.

Key Responsibilities

• Develop validation master plans, protocols, and reports for manufacturing processes, cleaning, equipment, and analytical methods.
• Execute validation protocols, including IQ, OQ, and PQ, ensuring data integrity and accuracy.
• Analyze validation data, assess results against pre-defined criteria, and write comprehensive validation reports.
• Identify and investigate any deviations or discrepancies encountered during validation activities.
• Collaborate with manufacturing, engineering, quality control, and quality assurance departments to ensure successful validation.
• Ensure all validation activities comply with cGMP, relevant guidelines (e.g., FDA, EMA, COFEPRIS), and internal SOPs.
• Maintain validation documentation and records in an organized and accessible manner.
• Participate in regulatory inspections and internal audits related to validation activities.
• Stay updated on industry best practices and regulatory expectations for process validation.
• Provide training and guidance to other personnel on validation requirements and procedures.

Requirements

• Bachelor's degree in Pharmacy, Chemical Engineering, Biotechnology, or a related scientific discipline.
• Minimum of 3 years of experience in process validation or a related role within the farmacéutico industry.
• Solid understanding of validation principles (IQ, OQ, PQ) and statistical analysis.
• Knowledge of cGMP regulations and guidelines applicable to pharmaceutical manufacturing.
• Experience with different types of pharmaceutical processes (e.g., sterile manufacturing, oral dosage forms, biologics).
• Strong technical writing skills with the ability to produce clear, concise, and accurate documentation.
• Excellent analytical and problem-solving skills.
• Ability to manage multiple projects simultaneously and meet deadlines effectively.
• Proficiency in Microsoft Office Suite and familiarity with validation software is a plus.
• Strong organizational and communication skills, essential for remote collaboration.

Benefits

• This remote position offers a competitive salary, the flexibility to work from home, and the opportunity to contribute to a critical function within the farmacéutico sector.
• Our client provides a supportive remote work environment and access to necessary project documentation.
• You will gain valuable experience in ensuring regulatory compliance and product quality.
• This role is ideal for a self-motivated professional seeking challenging validation projects without the need for on-site presence.
• We offer opportunities for professional development within the quality and compliance domain.