Expansion Validation Lead - cGMP Equipment & QA

Piramal Pharma Limited; Lexington (VA); On-site; USD 70,000 - 110,000; Full time

Job summary

Piramal Pharma Limited in Lexington is seeking an Expansion Validation Specialist to execute validation and qualification protocols for manufacturing, packaging, and laboratory systems in a cGMP environment. You will liaise with 3rd parties and internal teams to ensure timely project delivery from URS through to CX and RA documentation.

The role requires a Bachelor's degree in science or engineering and 2+ years of QA/regulatory experience.

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 preferred.
• Thorough knowledge of cGMP regulations, guidance, and compliance expectations.
• Technical writing skills.
• Root cause analysis, risk assessment and technical report writing.
• Working knowledge of EDMS, Trackwise and SAP.
• Proficiency in Microsoft Office applications.
• Excellent communication, both written and verbal.
• Detail oriented and organized.

Responsibilities

• Write, schedule, plan, manage and execute validation and qualification protocols.
• Act as technical interface between the company and 3rd parties for on-site validation discussions.
• Coordinate with Operations, Technical Services, Facility Engineering, Microbiology and QA groups to ensure project success.
• Lead qualification activities and timelines for equipment purchased for manufacturing.
• Coordinate order timelines and equipment requirements with Technical Services.
• Represent validation at project team meetings and provide expert validation advice.
• Independently design, plan and manage own studies.
• Develop documents for new equipment: URS, DQ, CX, RA.
• Maintain up-to-date knowledge on regulatory expectations and validation processes.
• Lead investigations related to validation discrepancies and ensure thoroughness of documentation and closure.
• Implement preventive/corrective actions as necessary.
• Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
• Author assigned SOPs for Validation department.

Skills

Technical writing

Root cause analysis

Risk assessment

Communication skills

Detail oriented

Education

Bachelor's degree in science or engineering

Tools

EDMS

Trackwise

SAP

Microsoft Office

Job description

Piramal Pharma Limited in Lexington is seeking an Expansion Validation Specialist to execute validation and qualification protocols for manufacturing, packaging, and laboratory systems in a cGMP environment. You will liaise with 3rd parties and internal teams to ensure timely project delivery from URS through to CX and RA documentation.

The role requires a Bachelor's degree in science or engineering and 2+ years of QA/regulatory experience.