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Title:  Sr. Specialist - CSV

Job Summary/ Main Purpose:

 

Provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/ Computerized System Validation CSV standards and practices. Ensures that all Gxp computerized systems (Mfg, Engineering and IT systems) used for supporting Manufacturing, packaging, facility maintenance is appropriately validated and controlled as per the standards. To ensure that the standalone manufacturing, packaging and engineering systems are tested for access control, audit trail, functions, and backup files/records by coordination with validation team. To perform as IT oversight and compliance to all IT systems like SAP, Infrastructure qualification, Data centre controlled and monitoring etc. Managing and leading the CSV team to ensure the team followed and validated the GxP computerized systems in accordance with Julphar approved procedure/s.

Key Responsibilities & Key Result Areas:

 

  • Subject matter expert on SDLC/CSV procedure and able to provide CSV guidance to IT or other relevant Business departments.
  • Support the teams for handling Auditors (Internal/External) related to IT GMP validation with the right kind of approach and strategy. Help project teams define appropriate CSV strategies including stage gate deliverables.
  • Prepare or review all levels of CSV documents (internal or external) including: eg. CSV (Strategy) Plans, User Requirement Specification etc.
  • Responsible for creation and routing of CSV deliverable like risk assessment, user requirements spec, validation plan, qualification protocols/reports, traceability matrix, and data migration plan and system procedure in coordination with system owner/user.
  • Responsible for creation, execution and review of the test cases, test case execution review, test incident/defect management and status reporting of CSV as in points. Handling of eQMS activities like change control, deviation investigation, CAPA and audit management. And approval of such computerized systems QMS events in the eQMS system.
  • Reviews, writes, revises and maintains all computerized GxP related policies/SOPS and company regulations to team members, system owner and users. Compile and analyze validation data and make recommendations for changes and/or improvements.
  • Performs periodic reviews or re-qualifications to maintain current validation status of IT base software's and systems as defined by approved validation SOPs.
  • Contribute directly to the completion of the key GxP projects through development and execution validation change control documents and development review of protocols, reports and data tables generated by vendors and contract personnels.
  • Work with business system owners and team to support internal and external audits across, to confirm compliance of the system with local and regional standards.
  • Responsible for preparing and maintaining the computerized system inventory for all Julphar sites/departments. Responsible for management CSV validation documents like archiving, retrieving and distribution. Prepare, review, and execute spreadsheet validation documents.
  • CSV support for analytical GxP computerized systems to the AS& T qualification team and review the executed documents as CSV SME to ensure the systems meets the Julphar approved procedure/s.
  • Review and approval of IT and GxP computerized systems access requests as an IT oversight especially for IT systems and central critical GxP systems. Responsible for review of access control, audit trail review and backup/restoration procedures prepared by CFTs to ensure the procedures are meeting the expected standards.
  •  Support, review and execution of GxP spreadsheet validation documents. Responsible to ensure that gap assessment study performed for all GxP legacy systems in Ensure all GxP computerized systems are appropriately documented and validated.
  • Responsible for the Hardware and Software Validation for the Major Equipment’s which is embedded with 21 CFR part 11 Compliant.

 

Core Competency

 

  • High on process compliance and implementation skills.
  • Strong understanding and practice of consciousness.
  • Responsible in approach, high on accountability and ownership.
  • Excellent team building, strong time and task management.
  • Excellent in command in English.
  • Highly disciplined, motivated and organized.

 

Qualifications / Key Experiences / Functional Knowledge Requirements

 

  • Bachelor/master's in computer science/ Pharmaceutical/ Engineering.
  • Solid understanding of Computer Systems validation of Manufacturing, Quality and Engineering systems.
  • Real Time Experience in the companies having GMP approval for USFDA/MHRA/TGA/ANVISA/EU authorities.
  • Fluent in English (communicating, writing and speaking).
  • Proficient in MS Office (MS Excel and MS Word, etc.).

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