Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Post : Senior Executive (53189)
Department : Quality Assurance – GMP - Biologics
Job Description :
Job Purpose : Training, Documentation, Qualification, Validation and CSV support
Key responsibilities
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.
• Compliance to Syngene’ s quality standards at all times.
• Hold self and their teams accountable for the achievement of safety goals.
• Govern and Review safety metrics from time to time.
• Maintain specimen signature logbook and ensure the signature of employees recorded before starting the work.
• Prepare/update training matrix/training curricula for an employee/job based on the need in consultation with the Department head and reporting manager.
• Ensures that the training needs of all employees in the department are completed.
• Responsible for updating classroom/OJT training attendance and related data in the LMS.
• Archiving of training records of respective departmental employees.
• Ensures training records of resigned employees are stamped and archived as per the procedure.
• Creating and uploading SCORM content learning items, content objects, assessments, tasks, checklists etc. in LMS and assigning/ mapping of cross-functional procedures to users as applicable.
• Track and report due date compliance of assigned trainings for the team/ department in LMS.
• Responsible for identifying and maintaining the training records of all the approved service providers.
• Ensuring Documentation control is maintained though out the Department and Co-ordinate for EDMS activities daily
• Supporting Equipment Qualification and Validation as per GAMP5, Ensuring Part 11 Compliance in place for all CSV systems
Candidate Profile :
• M.Sc / B.Tech / M.Tech
• Equipment Qualification as per GAMP5, Ensuring Part 11 Compliance in place for all CSV systems and Training and Documentation Coordinator
• Minimum 3-6 years
• Presentation skills, Leadership skills, Communication skills, Report writing and Documentation.
Additional Information
Experience : 3-6 years
Qualification : M.Sc / B.Tech / M.Tech
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022
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