Senior Consultant

2 weeks ago

Bengaluru, India PQE Group Full time

An international group, PQE operates in over forty-five countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets. Further information can be found at


Currently we are looking for a Senior Consultant – IT Infrastructure Qualification & CSV basted out at Nagavara Bangalore location with one of the Giant Pharma Takeda Pharmaceutical to handle their various projects in India and oversees. For initial 9 Months you will be on PQE Role then Takeda will Absorb the candidate on their role.


RESPONSIBILITIES:

·Provides Overall IT Infrastructure Qualification & CSV guidance and Support to the Agile Teams (E.g.: Product Owners, SME’s, testers. Developers, QA) for projects handled via agile infrastructure qualification and similarly, to project teams if project is managed via waterfall method.

·Responsible for defining the risk based qualification strategy with the team to ensure fulfillment of intended use and conformity with applicable internal and external regulatory requirements.

·Responsible for verifying that relevant processes and procedures are applied, as defined in the client’s QMS i.e. , Infrastructure Qualification, change and release management , third party assessments etc.

·Create qualification plans and summary reports.

·Review qualification deliverables and approve per governing processes e.g., Test Cases.

·Liaise with entire Cloud Team, QA, C&DT, Application Teams, and other related functions.

·Lead Infrastructure qualification related training activities for product teams.

·Provide regular reports on project/operational support related to infra qualification activities.


SKILLS AND EXPERIENCE :

  • have experience working in agile environment and use of modern quality tools e.g., (JIRA, CONFLUENCE, QTest etc.
  • knowledge of General IT strategy, IT Infrastructure and system’s cloud technology preferable AWS, DevOps, Applications and tools.
  • working with virtual teams on global basis.
  • depth knowledge of GxP regulations (such as from FDA, EMA, et) related to IT Systems and infrastructure.
  • to lead teams in the correct interpretation of regulations.
  • Oral and written communication skills, business acumen with problem solving and analytical skills.


Tools Knowledge Required : HPALM, JIRA, Q Test etc.


Job Location: Bangalore (Takeda Pharmaceutical)

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