Associate Director Tech & Scientific Computing

10 - 15 years

35 - 40 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Summary
Oversee all aspects of quality management and ensure the highest level of compliance across our projects
About the Role
Major accountabilities:
  • Oversee & support all areas of quality management for GxP/non GxP Systems.
  • Drive the validation process, including validation planning, testing (IQ/OQ/PQ), and validation reporting.
  • Support Authoring, reviewing, and approving of CSV deliverables for accuracy, consistency, clarity and completeness.
  • Ensuring all the validation SOP/Work Procedures are followed during the application development.
  • Coordinate with project managers and teams to ensure the alignment of project outputs with quality standards.
  • Evaluate data and QM processes to identify improvements to enhance efficiency and accuracy.
  • Manage change control processes for tool updates and deployments while driving continuous improvements in validation and quality workflows.
  • Support in audits and inspections to ensure adherence to compliance regulations and industry standards. Create and maintain documentation of processes and validation activities and provide training to teams on quality standards and procedures.
  • Oversee root cause analysis, corrective actions, and preventive actions to address quality issues. Ensure all systems and software used meet industry regulations and data integrity rule
Minimum Requirements:
  • Minimum of 10 years experience in Quality Management, ideally within the Pharma or any regulated industry.
  • Proven experience in managing GxP/non GxP projects from requirement definition to retirement.
  • Working experience in all lifecycle stages of IT system(including System retirement) would be preferred.
  • Ability to drive innovative validation strategies for business initiatives
  • Knowledge of IT systems and software used within the Pharma industry.
  • Exceptional leadership skills with the ability to drive a team towards meeting quality standards.
  • High attention to detail with the ability to identify potential risks or issues.
  • Solid interpersonal skills, including the ability to build and maintain effective working relationships.
  • Ability to influence and drive collaboration across all levels of the organization.
  • Bachelors degree in IT, Pharmacy or related field.

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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