QA ( Validation ) Senior specialist

Purpose of the Role

The QA Validation Senior Specialist is responsible for managing and overseeing all validation activities, ensuring that products and processes comply with regulatory requirements, company standards, and customer expectations. This includes equipment, process, cleaning, and computer system validations.

Key Responsibilities

1. Validation Management
   • Develop and implement validation plans, protocols, and reports for equipment, processes, and cleaning.
   • Oversee and ensure the timely execution of validation activities (IQ, OQ, PQ).
   • Ensure compliance with GMP, regulatory standards, and company procedures in all validation activities.
2. Team Leadership
   • Lead and manage the QA validation team, providing technical guidance and support.
   • Assign and prioritize tasks to ensure the timely completion of validation projects.
3. Regulatory Compliance
   • Ensure all validation documentation is accurate, complete, and audit-ready.
   • Stay updated on regulatory changes and industry standards to maintain compliance.
4. Risk Assessment
   • Perform risk assessments for equipment, processes, and cleaning procedures.
   • Identify critical parameters and ensure validation covers these aspects effectively.
5. Continuous Improvement
   • Recommend and implement improvements in validation procedures and processes.
   • Evaluate and optimize current validation practices to increase efficiency.
6. Cross-functional Collaboration
   • Work closely with production, engineering, quality control, and R&D teams to ensure smooth validation processes.
   • Provide validation-related training to employees as needed.
7. Audit Support
   • Support internal and external audits by providing validation documents and addressing audit findings.
   • Lead efforts to resolve validation-related observations from audits.

Qualifications

• Education: Bachelor’s degree in Pharmaceutical Sciences
• Experience: Minimum 7+ years of experience in quality assurance with a strong focus on validation, preferably in the pharmaceutical industry
• Technical Skills:
  • Strong knowledge of GMP and regulatory requirements.
  • Proficient in writing and reviewing validation protocols and reports.
  • Experience with validation of equipment, processes, and cleaning procedures.
• Soft Skills:
  • Strong leadership and communication skills.
  • Excellent problem-solving and analytical abilities.
  • Attention to detail and ability to manage multiple tasks simultaneously.

Key Performance Indicators (KPIs):

• Timely completion of validation protocols and reports.
• Compliance rate with GMP and regulatory standards.
• Reduction in validation-related audit findings.
• Efficiency in validation processes and resource utilization.