Position:

Sr. Manager

Job Title:

Lead Quality Projects

Job Grade:

Sr. Manager

Function:

Global Quality & Compliance

Sub-function:

Managers Job Title:

Skip Level Managers Title:

Function Head Title:

Location:

Tandalja, Vadodara (Gujarat)

No. of Direct Reports (if any)

2

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 Companys 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 SMEs 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 SOPs and to ensure implementation Harmonized SOPs 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 projectsto 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.

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

M.Sc., B. Pharma,

Specific Certification

Skills

Good Communication skill

Technical writer capability

Excellent presentation skill

Experience

16 Years

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Position:

Sr. Manager

Job Title:

Lead Quality Projects

Job Grade:

Sr. Manager II, G9B

Function:

Global Quality & Compliance

Sub-function:

Managers Job Title:

Skip Level Managers Title:

Function Head Title:

Location:

Tandalja, Vadodara (Gujarat)

No. of Direct Reports (if any)

2

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 Companys 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 SMEs 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 SOPs and to ensure implementation Harmonized SOPs 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 projectsto 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.

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

M.Sc., B. Pharma,

Specific Certification

Skills

Good Communication skill

Technical writer capability

Excellent presentation skill

Experience

16 Years

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.