Job Description

Job Summary:

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 \xe2\x80\x9cculture of quality\xe2\x80\x9d 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.

Job Responsibilities:

• To support compliance leader and business owner.
• 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 ensure maximum automation and system upgrade wrt compliance and usability.
• To support for site wise rollout plan along with other stakeholders and monitor the execution.
• To escalate and discuss roadblocks / updates with stakeholders.
• To ensure creation of centralized excellence team for each projects, which ensures participation of SME\'s from different region, different site complex or noncomplex. (depending on the objective and scope of the project)
• To develop, implement and monitor governance structure for the projects, this ensures effort estimation, involvement and deliverables from cross functional team and escalation for the key milestone or expected risk for the projects.
• 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 ensuring active collaboration from IT, Regional quality, SGO, API and sites as appropriate, and the nature of the project.
• To develop centralized business team at corporate or site.

• To ensure successful handover of the projects to their respective business owners, upon completion.
• To ensure that computerized systems are assessed against the requirement of part 11 and Annex11.
• Ensure the site GxP computerized system compliance in timely manner with the support of site compliance team for continuous improvement.
• Support sites with respect to computerized system validation and management.
• Provide support for suppliers and vendors audit, who impact development, implementation and maintenance of site/global computerized system.
• Provide guidance to remediate the legacy/non-compliant computerized system at site, to ensure compliance with current regulatory standards.
• Identify and support for implementing the global Quality-IT initiative.
• Support for implementing LIMS 6.x
• Manage remediation programs and prioritized based on risk.
• Support site before and during the regulatory audits.
• Support the site to comply the internal/external audit observation.
• Develop and maintain the quality of computerized system to ensure compliance with internal/external regulatory requirements.
• Lead the creation and implementation of relevant quality procedures for computerized system (SOPs)
• Provide support in the education of personnel in relevant areas for IT systems
• Ensure key documentation of computerize system consistently meets the required quality standards throughout its lifecycle.
• Ensure IT Quality processes and standards are aligned throughout collaboration with the Quality Assurance function.
• Ensure resolution of identified quality exposures in a timely manner.
• Support the closure of the global IT system related actions as and when required.
• Providing functional expertise during software development lifecycle to assure that validation of GXP IT system is planned and executed for user requirements and intended use.
• Support project for simplification and productivity enhancement initiatives.

ase of absenteeism, responsibilities can be delegated to the peer and/or in line manager

• Perform other duties as assigned by functional head time to time.
• To perform the activities as per the project plan for newly identified projects.

Sun Pharmaceutical Industries