QA Validation Specialist

Purpose :

The Quality Validation Specialist oversees the Qualification and Validation (Q&V) activities to ensure compliance with GMP requirements and internal standards.

He/she ensures the execution of validation protocols, evaluates the effectiveness of corrective actions, participates in audits and inspections, reviews maintenance plans, and coordinates quality events related to validation activities.

Duties and Responsibilities :

• Defines the scope of qualification and validation activities and monitors their progress;
• Ensures all qualification/validation documents comply with current regulations;
• Verifies the availability of necessary documents for validation activities;
• Reviews validation master plans, protocols, and reports, ensuring their adequacy and completeness;
• Prepares and approves validation protocols and reports for cleaning procedures and shipping validation;
• Supports validation activities carried out by external collaborators;
• Participates in executing validation protocols, reviews results, and defines corrective actions;
• Reviews standard procedures related to validation;
• Ensures the application and effectiveness of corrective actions;
• Approves and archives qualification and validation documentation;
• Participates in audits and inspections by regulatory agencies;
• Reviews maintenance and calibration plans, and evaluates analytical methods;
• Develops sampling plans following deviations and manages out-of-specification data;
• Coordinates investigations of quality events and implements CAPA activities;
• Evaluates change controls within their area;
• Ensures compliance with legal and corporate regulations;
• Contributes to quality system reviews and management reviews;
• Ensures compliance with laws and internal control standards.

Education :

• Bachelor's or Master's Degree in Biotechnology, Biology, Pharmacy, Chemistry, or related field;
• 5-7 years of experience in the pharmaceutical or life sciences quality sector.