Validation Specialist Jobs

TITLE: Validation Specialist

DEPARTMENT: Innovation, Development and Transfer Services

POSITION REPORTING TO: Technical Manager

General Description:

• Responsible for Process Validation of the manufacturing and packaging processes for Solid Dose, Liquid and Semi Solid Dosage forms, and support investigations.

Responsibilities:

• Perform internal self inspections of the technical area and ensure compliance with internal and Regulatory standards
• Conduct validation reviews and prepare Process Validation Summary reports
• Participate in investigation for deviations and product incidents that impact validation. Review investigations related to validation and help identify root cause and assign and/or complete appropriate CAPAs.
• Respond to process validation queries from Regulatory authorities and clients in a timely manner
• Interpret and apply QMS and regulatory requirements, updating procedures as required.
• Prepare, review, and execute Performance Qualifications (PQs) protocols, Bulk Hold protocols, validation/bulk hold summary reports and validation master plans
• Uses product and process knowledge as the basis for risk-based validation and continuous verification programs
• QMS documents pertaining to the area of responsibility are reviewed and risks evaluated in a timely manner
• Assess changes in process, API, Raw materials or components for their impact on process validation

Qualifications:

Experience and Skills

• Good understanding of the principles of process validation
• Knowledge of GMP, Quality Control, Quality Assurance, Production or Engineering
• Strong technical writing skills and attention to detail.
• Able to make informed decisions on validation approach and requirements
• Strong interpersonal and communication skills.
• Minimum 3-5 years of pharmaceutical experience
• Demonstrate ability to participate in constrained projects with exact timelines.

Education

Required:

• Bachelor’s Degree in science or related field or equivalent on the job experience 2+ years of service.

Preferred:

• Additional knowledge of the pharmaceutical manufacturing and packaging industry or other regulated industry

WORKING CONDITIONS:

• Mainly office environment with regular visits to production area. Require the use of PPE to prevent exposure to hazardous materials when in production area.