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Lead Quality Projects

3 months ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Role :

Responsible for developing, applying appropriate quality systems to ensure Quality Systems, projects, processes and services meet their business and regulatory requirements.

Follow the overall GxP strategic direction for all Quality activities and ensure consistent compliance of GxP systems with regulations and corporate quality policies, programs and objectives.

Support building a "culture of quality" across the organization, assess compliance and operational issues of the Company, providing strong leadership, expertise, setting and maintaining Quality standards throughout the Company's complete value chain.

Areas Of Responsibility :

To support Business owner for the timely execution and completion of qualification activities.

To identify the actionable and accomplish the project milestone.

To monitor the project execution and support for preparation of Project Management Plan.

To ensure that projects are designed and executed as per the compliance requirements.

To ensure that the tools and solutions can cater business requirements.

To review and approve qualification script, and ensure PQ execution activities as per approved script.

To review and approve documents related to project.

To ensure support to business during execution, qualification as well as Post Go-Live of all application and resolve their issues, if any.

To ensure support for database creation, preparation and designing of execution sheet of each project.

To perform functional testing with positive and negative challenge with logical program, as and when required.

To ensure technical training / support for each site, whenever required.

To prepare and review SOP/protocol related to project.

Support to Site SME's and business owner for Stabilization of projects at all sites.

To support Business owner for the timely execution and completion of qualification activities.

To identify the actionable and accomplish the project milestone.

To monitor the project execution and support for preparation of Project Management Plan.

To ensure that projects are designed and executed as per the compliance requirements.

To ensure that the tools and solutions can cater business requirements.

To review and approve qualification script, and ensure PQ execution activities as per approved script.

To review and approve documents related to project.

To ensure support to business during execution, qualification as well as Post Go-Live of all application and resolve their issues, if any.

To ensure support for database creation, preparation and designing of execution sheet of each project.

To perform functional testing with positive and negative challenge with logical program, as and when required.

To ensure technical training / support for each site, whenever required.

To prepare and review SOP/protocol related to project.

Support to Site SME's and business owner for Stabilization of projects at all sites.

To escalate and discuss roadblocks / updates with stakeholders.

To conceptualize and frame a consolidated approach for new identified requirements.

To ensure support vendor for Technical discussion for finalization of application functionalities.

To ensure review of application functionalities as per current procedure through virtual testing.

To coordinate operational change management / test activities to ensure ongoing compliance with business and regulatory requirements.

To ensure collection of pre-requisites for newly identified projects.

To perform the activities as per the project plan for newly identified projects.

To ensure activities related to harmonization of SOP's and to ensure implementation Harmonized SOP's for calibration across sun sites.

To implement GSOP/GQS for harmonized procedure.

To update the issue tracker for the projects handled and support for closure of the issues.

To support any other project initiated for simplification and productivity enhancement.

To work in collaboration with IT, API, SGO, Site Quality and different teams for identification of the right solution / tool / Vendor, to resolve the "Specific problem statement" and have correct solution for the organization.

To ensure successful handover of the projects to their respective business owners, upon completion.

Support sites during the regulatory audits and internal/ external audit observations.

The above list is not exhaustive and may be assign additionally responsibility from time to time. In case of absenteeism, responsibilities can be delegated to the peer and/or in line manager.

Educational Qualification : M.Sc., B. Pharma, (experience in Cleaning Validation is mandatory for this role)

Experience : 16 Years

Job Grade : Senior Manager