Consultant

Company Description DevShreeTech Innovations Pvt. Ltd. is a professional services organization focused on delivering high-quality, regulation-compliant, and technology-enabled solutions to clients in the pharmaceutical, biotechnology, healthcare, and life sciences sectors. The company supports organizations in maintaining regulatory compliance, strengthening quality management systems, improving operational efficiency, and ensuring the reliability of computerized and regulated processes. Its service portfolio includes Computerized System Validation (CSV), Commissioning, Qualification, and Validation (CQV), IT auditing, pharmacovigilance, medical writing, and clinical trials management. DevShreeTech combines specialized technical expertise, quality-driven methodologies, and deep regulatory knowledge to provide practical, risk-based solutions tailored to client needs. The team is committed to aligning every engagement with current industry standards and best practices.
Role Description This is a Contract or Freelancer position as Consultant role. The Consultant will work at clients site in pharmaceutical company. Daily responsibilities include conducting gap analyses, supporting CSV and CQV activities, preparing and reviewing technical and regulatory documentation, and contributing to risk assessments and remediation plans. The role involves collaborating with cross-functional client teams, providing actionable recommendations, and helping implement improvements that enhance compliance, efficiency, and data integrity. The Consultant will also support knowledge sharing, contribute to internal methodologies, and stay current with evolving regulations and industry guidelines.
Qualifications
Strong understanding of regulatory frameworks and quality systems relevant to pharmaceutical, biotechnology and life sciences (e.g., GxP, FDA, EMA, ICH guidelines).
Experience with Computerized System Validation (CSV) and Commissioning, Qualification, and Validation (CQV), including validation planning, test execution, documentation, and reporting.
Skills in IT auditing, data integrity assessment, and evaluation of computerized systems and regulated processes.
Ability to contribute to pharmacovigilance, medical writing, and clinical trials management activities, including preparation and review of scientific, clinical, or safety documentation.
Strong analytical, problem-solving, and risk assessment capabilities, with the ability to propose practical, risk-informed solutions.
Effective communication and stakeholder management skills, including the ability to present findings and recommendations clearly to technical and non-technical audiences.
Proficiency with common office and documentation tools; familiarity with validation tools or quality management systems is an advantage.
Bachelor’s or Master’s degree in pharmacy, life sciences, biotechnology, engineering, or a related discipline; relevant certifications in validation, quality, or auditing are a plus.
5-10 years experience candidate preferred.

Work arrangement
No