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Job details:
Company Description CPF - Center of Pharma Force is a collaborative platform dedicated to the learning and development of pharma professionals. It enables individuals to share perspectives, knowledge, and recent updates on pharmaceutical regulations in India and globally. Through community-driven learning, professionals can deepen their expertise and stay current with industry standards. CPF also focuses on mentoring and training junior professionals, supporting career growth and long-term development. The organization promotes a culture of continuous improvement and knowledge exchange across all levels of the pharma sector.
There is a requirement for CSV experts who are immediate joiners for a 5-6 months long project.
Role - CSV Expert
Experience Range - 2 to 10 years
Job Description:
- Validation Documentation: Author, review, and execute key validation lifecycles like User Requirements Specifications (URS), Functional Specifications (FS), Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Validation Summary Reports and ensure compliance and adherence with client’s guidelines procedure and regulatory standards.
- Risk & Compliance Management: Perform GxP assessments and risk analyses utilizing Gamp5 Framework and ICH Q9 concepts. They lead the transition from traditional heavy documentation to risk-based Computer Software Assurance (CSA). Data Integrity Enforcement: Audit system security controls, access privileges, and electronic audit trails to maintain continuous alignment with ALCOA+ principles and regulations like FDA 21 CFR Part 11 / EU Annex 11.
- Change Control & Maintenance: Evaluate hardware or software upgrades to ensure changes do not compromise the system’s validated state.
- Audit Representation: Serve as the Subject Matter Expert (SME) to defend system validation protocols during regulatory agency inspections (e.g., FDA, EMA).
- Please DM us or send your profile on pharmaforce10@gmail.com
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