Advisor, Computerized Systems

3 - 6 years

10 - 14 Lacs

Posted:4 hours ago| Platform: Naukri logo

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Work Mode

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Job Type

Full Time

Job Description

  • Develop and incorporate effective processes and procedures and may contribute to business processes and procedures.
  • Assure computer systems meet regulatory requirements and that they conform to regulatory expectations.
  • May interact with regulators.
  • Support/Manage routine computer compliance assessments (internal & external)
  • as well as computer compliance initiatives of demanding high priority including regulatory inspections and high-risk non-compliance issues.
  • May lead initiatives, program, or team activities, as required.
  • May be responsible for coaching, mentoring, training others.
  • Identify computer related business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
  • Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices.
  • Assure compliance with computer compliance regulations and expectations and
  • GSKs related policies and procedures.
  • Provide computer compliance advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
  • Represent CSQA as a primary business contact.
  • Identify and mitigate computer compliance risks to GSK through effective assessments and/or via providing advice and consultancy to QA and business units regionally and globally.
  • Liaise with customers to provide computer compliance advice/input.
  • Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
  • Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs.
  • Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by management.
Job Related Experience
  • Demonstrable knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
  • Communications are clear, concise, well structured, authentic and easily understood.
  • Communicates and interacts at most levels both inside and outside of GSK.
  • May influence and negotiate at most levels and may interact with regulators.
  • Build and maintain effective internal GSK business relationships
Other Job-Related Skills
  • High degree of organizational awareness and in-depth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
  • Good understanding of medical/corporate governance principles and demonstrated ability to develop sound solutions for complex problems.
  • Communicate with clarity, impact and passion, tailored to the audience.
  • Ability to make complex ideas, simple.
  • Create an environment where open, transparent communication, especially providing and receiving feedback, is valued and trusted.
  • Create an environment of empowerment and remove barriers to empowered action.
  • Effectively utilize internal and external networks to influence key stakeholders.
  • Ability to understand and integrate diverse opinions and perspectives in setting and delivering business objectives.

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GSK India logo
GSK India

Pharmaceuticals & Biotechnology

Mumbai

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