Senior Qa/Validation Scientist

Our client is seeking an experienced Senior QA/Validation Scientist to play a pivotal role in providing QA support and oversight for validation, computerised systems, and technology transfer activities in strict compliance with regulatory requirements.

Responsibilities:

• Review and approve qualification protocols, discrepancies, and associated reports.
• Manage QA policies and SOPs, ensuring alignment with regulatory standards.
• Conduct GxP training sessions and serve as a point of contact for various departments.
• Represent the company during regulatory inspections.
• Lead and manage QA Validation and Computerised Systems Validation teams.
• Oversee key performance indicators (KPIs) and lead problem-solving initiatives.
• Ensure inspection readiness and promptly close GMP documentation in compliance with regulatory standards.
• Communicate effectively with regulators, and maintain professionalism under pressure.
• Demonstrate effective written communication skills.
• Exhibit leadership qualities, and a logical approach to problem-solving.
• Manage and support staff development, ensuring compliance with GMP, Data Integrity, and GDP.

Education and Experience:

• BSc in Life Sciences or related discipline.
• 8-10 years of experience in a GxP environment, with a focus on validation and computerised systems documentation.
• Previous experience in line management.
• Excellent practical knowledge of GxP regulations and guidelines related to validation and qualification.

Key Skills:

Validation expertise.

Active participation in risk assessment.

Knowledge of Good Distribution Practice (GDP) and HAZOP.

Proficient in report writing.

Scientific qualification and background.

Experience in Manufacturing, preferably in the Chemical/Pharmaceutical sector.

The successful candidate will have a strong awareness of all matters relating to environment, health, safety and quality, thereby ensuring compliance with company good practice and industry regulations.

To apply for this position, candidates must be eligible to live and work in the UK