CSV Analyst

Found in: Appcast Linkedin IN C2 - 2 weeks ago

India ProductLife Group Full time

Reporting into the Quality Services CSV Manager the role is a client interacting position providing support to Integrity CSV teams to ensure effective management of CSV documentation.

As an Analyst you will have the ability to work as part of team delivering quality and compliance solutions.

ROLE

• To support Computerised System Validation (CSV) and Data Integrity (DI) programmes / projects in accordance with client requirements, regulatory requirements, and industry best practices.

• To support the initial review of CSV / Quality Documentation to ensure Good Documentation Practices have been applied.

• To manage Document review and approval lifecycle and management of documentation within electronic systems

• To support the reporting of Documentation status.

• To facilitate adherence to documentation review cycle metrics (e.g. review turnaround)

• To support project reporting


KEY SKILLS

• To be a team player, providing support where required to colleagues.

• Clear communication skills to provide direction, communicate expectations and articulate opinions and solutions.

• To be able to effectively review documentation to ensure adherence to Good Documentation Practice.

• To be able to use technology (e.g. Document Management Systems)

• To be able to understand regulatory and customer requirements and processes

• To be able to assist/ manage projects within agreed timelines.

• To be able to generate status reports


KNOWLEDGE AND EXPERIENCE

Experience/Understanding of aspects of CSV projects:

• Understanding of CSV and Data Integrity Requirements (regulatory and industry best practice)

• Document Management experience beneficial

• Project Coordination experience beneficial

Qualification/Experience

• Degree in natural science, IT or equivalent business experience (preferred)

• Understanding of global regulatory requirements / guidance pertaining to computerised system validation e.g., US FDA 21 CFR Part 11; Electronic Records and Electronic Signatures, European Annex 11 Computerised Systems, PIC/S

• Understanding of global regulatory requirements / guidance relating to Data Integrity, MHRA, US FDA, WHO

  • • Understanding of industry good practices e.g., ISPE GAMP Guidelines and Good Practice Guides

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