About the Role
We are looking to hire a Computer Systems Validation (CSV) Specialists to join our Technology
and Transformation team. This position is responsible for managing the validation and
compliance of a number of GxP systems including databases and proprietary
systems/applications. The ideal candidate will have a strong computer system validation
background with extensive experience developing/updating validation project plans and writing
and reviewing performance qualification/user acceptance testing scripts. A keen attention to
detail is very important.
The candidate should be comfortable working in a global organization with a diverse and
collaborative culture.
Responsibilities
• Deliver CSV and roll-out activities within planned application changes and maintain
relevant documentation based on the application
• Write and review performance qualification and user acceptance test scripts that
adequately ensure business requirements are met for a given system
• Ensure close collaboration with appropriate system owners and key stakeholders in
the business
• Ensure compliance of GxP application’s operation and maintenance during its
operational life
• Provide system audit support and ensure inspection readiness of applications
• Work with QA, Computer Systems Validation Committee and IT to document CAPAs
and other quality items
• Review of database vendor's qualification documentation, as applicable
• Work with vendors for change control management, incident management and
issue resolutions
• Proactively identify and collate information required to assess compliance with
processes and prioritize business process improvement needs.
• Review, assess and update procedural documents for overall compliance with
current processes, as required
• Perform special projects, assignments, and administrative tasks per business needs
• Provide guidance and review or create varied support materials, presentations,
and/or tools to support department's remit and strategies.
• Proactively collaborate with initiative leads and senior management to develop,
optimize and improve CSV processes, training, and communications
• Mentor, coach and support team members
Requirements
Strong knowledge of software development lifecycle and CSV process
• Understanding of key Pharmaceutical compliance regulations like 21 CFR part 11,
Annex 11, GxP, GAMP 5 and SOX IT
• Ability to develop/update validation project plans and computerized system lifecycle
program documents to deliver large CSV projects
• Significant experience in authoring, reviewing and oversight of the execution of
qualification documents, specifically test scripts
• Strong problem-solving, verbal, written and presentation skills
• Proficient in Microsoft Office products (including Outlook, Word, and Excel)
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with
limited supervision
• Ability to maintain a positive and professional demeanour
• Ability to work effectively within a team to attain a shared goal
• Project management experience
Strong knowledge of software development lifecycle and CSV process • Understanding of key Pharmaceutical compliance regulations like 21 CFR part 11, Annex 11, GxP, GAMP 5 and SOX IT • Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSV projects • Significant experience in authoring, reviewing and oversight of the execution of qualification documents, specifically test scripts • Strong problem-solving, verbal, written and presentation skills • Proficient in Microsoft Office products (including Outlook, Word, and Excel) • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision • Ability to maintain a positive and professional demeanour • Ability to work effectively within a team to attain a shared goal • Project management experience
About the Company
MNC Client of Sebcs