EXPANSION Validation Specialist

Piramal Pharma Ltd; Lexington (KY); On-site; USD 65,000 - 85,000; Full time

Job summary

Piramal Pharma Ltd is looking for an EXPANSION Validation Specialist in Lexington. The specialist will execute validation and qualification protocols while ensuring compliance with cGMP and GEP. Key responsibilities include writing and managing validation plans and leading investigations related to discrepancies.

The ideal candidate should have a Bachelor’s Degree in a relevant field along with at least 2 years of QA experience and knowledge of the sterile manufacturing process.

Qualifications

• 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment.
• Sterile manufacturing of injectables strongly preferred.
• In-depth understanding of investigational techniques.

Responsibilities

• Write and execute validation and qualification protocols.
• Coordinate with Operations and Quality Assurance groups for project execution.
• Lead investigations related to validation discrepancies.

Skills

QA and Regulatory experience

Technical writing skills

Understanding of cGMP regulations

Microsoft Office applications proficiency

Organizational skills

Education

Bachelor’s Degree in physical or biological sciences or engineering

Tools

EDMS

Trackwise

SAP

Job description

Job Title

EXPANSION Validation Specialist

Location

Lexington

Department

Validation

Reporting Structure

This position reports to the Validation Supervisor.

Job Overview

Reporting to the Validation Supervisor, the Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.

Key Responsibilities

• Write, schedule, plan, manage and execute validation and qualification protocols
• Act as technical interface between the company and 3rd parties for discussions surrounding on-site validation activities
• Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project execution
• Lead qualification activities and timelines for equipment purchased for manufacturing purposes
• Coordinate order timelines and equipment requirements with Technical Services group
• Represent validation at project team meetings and provide expert validation advice
• Independently design, plan and manage own studies
• Manage the development of the following documents for new equipment:
  • User requirement specification (URS)
  • Design qualification (DQ)
  • Commissioning (CX)
  • Risk assessment (RA)
• Maintain and develop state of the art knowledge regarding existing and future validation processes and maintain up-to-date knowledge on regulatory expectations
• Lead investigations related to validation discrepancies and ensure thoroughness of investigation, documentation and closure
• Implement preventive/corrective actions as necessary
• Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles
• Author assigned Standard Operating Procedures (SOPs) for Validation department

Qualifications

• Bachelor’s Degree in the physical or biological sciences or engineering
• 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment
• Sterile manufacturing of injectables strongly preferred
• Thorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations
• Technical writing skills
• In-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writing
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)
• Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU)
• High level of proficiency operating all Microsoft Office applications
• Excellent communication skills, both verbally and in writing
• Detail oriented and organized