QA Validation Engineer — cGMP & Validation Leadership

Piramal Pharma Limited; Bethlehem; On-site; GBP 45,000 - 70,000; Full time

Job summary

Piramal Critical Care, a unit of Piramal Pharma, is seeking a QA Validation Engineer to drive the quality culture at the site and lead validation activities. You will own change management and ensure compliance with cGMP and regulatory standards while coordinating with operations, engineering and QA/QC teams.

The role involves planning and executing validation studies, writing protocols and reports, and supporting regulatory submissions.

Qualifications

• cGMP understanding and regulatory compliance knowledge for pharmaceutical environments.
• Excellent verbal and written communication across functions and levels.
• Proficient in Microsoft Outlook, Excel, Word and other web-based systems.
• Collaborative mindset with cross-department teamwork.
• Experience leading projects and driving validation activities.

Responsibilities

• Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility systems.
• Schedules, plans, manages and executes studies for cleaning validations.
• Schedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocols.
• Reviews and approves validation project documentation.
• Coordinates with process unit heads, quality and engineering groups to ensure successful project executions.
• Leads and coordinates cross-functional teams for project validation.
• Prioritizes and manages multiple projects using project management methodologies.
• Oversees external validation resources.
• Supports development of best validation practices and regulatory submissions when requested.
• Authors SOPs to ensure compliance with company policies.

Skills

cGMP

Regulatory Compliance

Professional Communication

Computer Literacy

Collaboration

Project Management

Education

Bachelor’s degree or higher in relevant scientific/technical field

Tools

MS Office

Job description

Piramal Critical Care, a unit of Piramal Pharma, is seeking a QA Validation Engineer to drive the quality culture at the site and lead validation activities. You will own change management and ensure compliance with cGMP and regulatory standards while coordinating with operations, engineering and QA/QC teams.

The role involves planning and executing validation studies, writing protocols and reports, and supporting regulatory submissions.