Project Manager

4 weeks ago

Bengaluru, India PQE Group Full time
We are a

service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998,

with more than 2000 employees, 45+ nationalities and

40 subsidiaries

all over the world

(Europe, Asia and the Americas). Joining PQE

means being a part of a

multicultural and challenging company,

with many

local and

international projects,

and colleagues from all over the world.

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 we are looking for a

Senior Qualification Lead (Project Manager - IT Infrastructure Qualification & CSV)

for Navatara

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 On Role.

You will be responsible for:

Provides Overall IT Infrastructure Qualification 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.

About you:

Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields).Experience in Pharmaceutical Sector as a must12+ years of experience in Project Manager -

IT INFRASTRUCTURE QUALIFCATION & CSVKnowledge/In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).Knowledge of FAT, SAT, IQ, OQ, PQ procedures and documentationEffective communication and interpersonal skills to collaborate with stakeholders at all levels of the organization.English: fluent (mandatory)

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues all over the world.

Apply now and take the first step towards an amazing future with us.

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