Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications for the world. We are hereby inviting candidates who are interested to join India's No.1 company in Pharmaceutical Sector.
Post : Senior Executive
Job Description
Overview :
Support annual mandatory GxP training management by creating courses/curricula in LMS, monitoring & tracking for their completion and generating monthly reports.
Assist new Learning Management System (LMS) Development or Enhancement Project Execution and maintenance of the system post implementation.
Ensure management of the training activities in LMS on routine basis in a compliant way at Global Domain.
Responsibilities include :
Annual Mandatory GxP Trainings :
• Creating and assigning annual mandatory GxP related courses/curricula in LMS and monitoring & coordinating with applicable sites for their timely completion and compliance i.e. Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) & Data Integrity & Reliability.
• Supporting the sites by conducting and facilitating these training courses if needed.
• Generating monthly reports in respect to these annual mandatory annual training reports.
During New System (LMS) Development or Enhancement Project Execution:
• Assists the Business Lead in obtaining buy-in for newly designed or changed processes.
• Participates in, or facilitates process definition and ensures processes are effectively mapped.
• Provides business expertise and resolves business issues.
• Communicates with business stakeholders with regards to process blueprint requirements, new process implications, changing environments, as well as facilitating buy-in.
• Responsible for creation and execution of formal test cases and checklists for systems.
• Assists with formal testing of the system
• Executes all project tasks in a timely fashion as per the project schedule, and notifies project manager of conflicts immediately.
• Attends and prepares for all project meetings and work sessions.
• Resolves project issues and change requests in a timely manner.
• Adheres to established change control processes, relevant SOPs.
• Assists in the identification/update of SOPs that need to be created, changed or deleted.
• Executes all necessary end-user training and local support.
System (LMS) Post Go-Live :
• Act as Subject Matter Expert (SME) and provide advanced process and systems knowledge for the assigned role.
• Provide first level support to the system end-users as required.
• Escalate issues to IT Helpdesk and Business Lead as required.
• Develop transactional expertise and keep current in system and business process knowledge within their specific functional area.
• Participate in Global SuperUser led meetings or other group activities to share knowledge and influence cross functional improvements.
• Provide feedback to Business Lead on suggested business process, training material, GSUM’s, Standard Operating Procedures and system improvements.
• Assist in the collection of data to report against established metrics as required.
• Participate in both internal audits and regulatory inspections as required.
• Support system change control process including, but not limited to:
* Participate in cross functional projects and/or discussions relative to new or existing processes or systems.
* Define and execute appropriate testing to ensure the system meets identified requirements.
* Support writing and execute validation test cases to ensure proper compliance and business risk testing have been completed.
* Assist Business Lead in communicating configuration and functionality changes to end users.
* Work closely with other SuperUsers where process and systems changes are cross functional in nature or in project scenarios where full validation is required (i.e. upgrades, patches, adding new locations, etc.).
* Implement systems changes to support regulatory compliance as notified.
* Support access and training relative to the assigned End-use role.
• Assess appropriateness of the requested end-user role and approve system access requests.
• Ensure all training materials, user manuals and GSUM’s are updated and kept current.
• Responsible for training of the new staff on business processes and system functionality for assigned role.
• Provide support to area trainers that may be providing on boarding training for new employees or recertification of existing employees.
• Mentor other potential additional site SuperUsers that have been identified by the Business Lead and site Leadership.
• Site specific LMS administrator privileges/rights.
• Creating and maintaining all LMS learning activities of the location (Domain/Department).
• Creating Learning Activity structure for all training (New and Revised), MTNM based activities and other training needs, as applicable.
• Review and approve system access Form as applicable.
• Uploading activities at the Domain Level.
• Creating Subscription links (PDF & Quick Assessment).
• Adding / Removing Job Roles.
• Assigning / Removing Training activities to Job Roles or users, as needed.
• Uploading revised version of existing activity and obsoleting or inactivating older versions.
• Waiving off of trainings or providing credit for training completion, as needed Requested by employee Immediate Supervisor/ Manager.
• Removing directly assigned pending activities for an employee upon leaving the organization or when transferring to another Department/ location.
• Provide reporting metrics to management as requested.
Candidate Profile
Education Requirement :
• Bachelor's or Post Graduate Degree Life Sciences, Pharmacy, or equivalent required Experience Requirement.
Experience Requirement :
• 7-10 years working in a pharmaceutical environment.
• At least 5 years program management within a Pharmaceutical Quality Environment, preferred.
• Strong understanding of GMP requirements and their application in a manufacturing environment, knowledge of international GMP requirements.
• Working experience in design and implementation of Learning Management System (LMS) & Training Programs.
• Strong communication, interpersonal and organizational skills
Additional Skills :
• Ability to function as a Global Superusers / Training Coordinators with a multi-cultural team in a global environment.
• Ability to work independently, take initiative and lead, inspire and motivate a team
• Technical expertise with SCORM based Content Developing Tool, MS Office and LMS
• Ability and aptitude in Training, demonstrated experience as an LMS SME.
• Ability to remain focused and effective in high stress situations.
• Excellent communication, presentation and inter-personal skills.
• Must have English language fluency, both written and verbal with the ability to communicate at all levels within the organisation.
Additional Information
Location : Tandalja - Vadodara
Industry Type : Pharma
Functional Area : R&D
End Date : 31st January, 2023
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