EXPANSION Validation Specialist

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Validation Specialist in Lexington to execute validation and qualification protocols across manufacturing, packaging, laboratory, and utility systems in alignment with cGMP and GEP. You will interface with 3rd parties, coordinate with Operations, QA, and Engineering, and author core validation documents.

The role requires a Bachelor’s degree in a physical/biological science or engineering with 2+ years in QA/regulatory environments and strong technical

Qualifications

• Bachelor’s Degree in physical or biological sciences or engineering preferred.
• 2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environment.
• Sterile manufacturing of injectables strongly preferred.
• Thorough knowledge of cGMP regulations, guidance, and general compliance expectations.
• Technical writing skills.
• In-depth understanding of investigational techniques, including root cause analysis and risk assessment.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP).
• Strong documentation and communication abilities.

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 activities.
• Coordinate 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.
• Develop documents for new equipment: URS, DQ, CX, RA.
• Maintain up-to-date knowledge on regulatory expectations.
• Lead investigations related to validation discrepancies and ensure closure.

Skills

QA experience

Regulatory experience

cGMP knowledge

Technical writing

Communication skills

SAP knowledge

Education

Bachelor’s degree in physical or biological sciences or engineering

Tools

EDMS

Trackwise

SAP

Job description

Be the First to Apply Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title EXPANSION Validation Specialist Job Description Business: Pharma Solutions Department: Validation Location: Lexington

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.

Reporting Structure

This position reports to the Validation Supervisor.

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 the 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 preferred.
• 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

Our Company

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.