Sr. Manager - Corporate Quality Projects
- Sun Pharma
- 12 - 17 years
- Mohali, Chandigarh
- 1 month ago
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Job Description
Job Summary:
Responsible for leading all activities associated with the Corporate Electronic Document Management System, acting as Enterprise Super user developing strategies supporting system upgrades, implementations, sustainability, and maintenance activities. Ensure customers and stakeholders are supported through a collaborative approach to communication of changes across the enterprise. Responsible for effective partnership with IT, QAIT and Sun sites to ensure business needs and requirements are being met and interpreted consistently across the organization.
Job Responsibilities:
- Understanding of platform/system qualification and its cross site implementation to assure the GxP computerized systems are compliant with applicable regulatory requirements.
- To support the validation of GxP Application Systems including Enterprise Systems, Backup systems, electronic inventory and user access management system and other computerized systems to comply with regulatory guidelines.
- To define Validation Strategy & plan, review and system readiness CSQMS documentation.
- To support the various phases of Computer System including Planning, Qualification, Implementation, Maintenance and retirement activities by ensuring compliance with internal / external regulatory requirements.
- Collaborate with Business team to prepare Business case studies.
- Gather Project business and technical requirements in order to develop project estimates.
- Work with Digital platform and application team for future developments and releases.
- Create and execute project plans with IT leads, and revise as appropriate to meets changing needs and requirements.
- Identify vendors and perform vendor application evaluation along with IT and Business users.
- Collaborate with IT Project Managers to execute projects, ensuring that teams have appropriate product and technical specification, direction, and resources to deliver products effectively by establishing realistic estimates for timelines and ensure project meets deadline.
- Work with IT project manager to ensure effective and efficient communication and execution of program and Train business users.
- Provide support to sites on handling/troubleshooting technical/understanding issues related to Global applications. Handing of Incidents related to functionality of Global application; participate in investigation process to find the root cause and implementation of CAPA.
- Ensure each issue is tracked and resolved in timely manner as a part of procedure elaboration, enhancement.
- Responsible for management of Global Standard Operating Procedure and Global System User Manual for electronic systems.
Requirements and Qualifications :
- Bachelor's degree in Life Sciences or Pharmacy or Information Technology or equivalent
- Minimum 10-15 years working in a pharmaceutical environment
- Minimum 5 years progressive experience with enterprise applications with knowledge of CSQMS documentation and CS-Lifecycle Management.
- Subject Matter Expert who understands the details of business process within documentation management functional area.
- Ability to learn new application capabilities and relate to potential business opportunities as it relates to efficiency and return on investment.
- Strong organization skills, team player, customer focused.
- Ability to develop and maintain positive working relationships, clarify expectations and seek understanding.
- Excellent oral and written communication skills.
- Strong facilitation and training skills.
- Applicable knowledge of GMP, cGMP and their relationship to process design, computer systems and validation.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area: Pharmaceutical & Life Sciences
Role Category: Quality Assurance - Other
Role: Quality Assurance - Other
Employement Type: Full time
Contact Details:
Company: Sun PharmaLocation(s): Mohali, Chandigarh
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Sun Pharma
From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by...
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