Support all the activity related to the serialization project by deploy the validation and qualification strategy related to serialization, such as computerized system validation process, qualification equipment, provide Standard Operating Procedure that related serialization activity, Master Batch Record that impact with serialization project and other documents that related with serialization project also ensure all transfer activities conduct are in compliance with all regulatory and technical requirement.
Responsibilities :
§Coordinate the planning for validation and qualification with the related department (plant supply chain, quality, production, engineering, ITS, and Serialization Global Team)
§Conduct validation dan kualifikasi activity in coordination with WH and Production Department
§Write protocol, execute the process and write report for validation dan qualification process related to serialization project
§Ensure that all the equipment and consumable to support validation and qualification are available to respect the project planning
§Prepare all the documentation to support the regulatory dossier.
§Act as key point of contact for project product transfer related to validation and qualification.
§Establish SOP or document describing the new process or equipment and establish training if required
§Master Batch Record Revision that impact due to serialization implementation in JAKARTA site
§Facilitate exchange of information between third party / vendor and Jakarta Site.
§Report to direct supervisor and quality manager if found any deviation during validation and qualification activity
§Actively involve in continuous program in his/her workplace.
§Implement HSE practice in the workplace.
Competencies & Skills :
Technical Skill & Competencies/Language
§Technical Equipment Know How (Technical Equipment Maintainance).
§Business process analysis (general business knowledge)
Behavioral Competencies
Core Competencies:
§Strive For Result (Exceed Standard Performance)
§Act For Change (Participating In Change)
§Corporate Transversally (Leverage Team Work)
§Commit To Customer (Take Responsibility To Fulfill Customer Needs)
General Competencies:
§Continous Learning (Practical & Actual Learning).
§Analytical Thinking (Break Down Issues).
§Committed To Org. Ethic (Act With Integrity)
§Communication (Clear Message).
§Adm, Record, Data Handling, Planning & Organizing (Reporting & Administration Understanding).
Qualifications :
Apothecary program graduated. Fresh graduate / Minimum 1 year experience in pharmaceutical company. Broad knowledge of GMP Computer Literate English Literate is a must Willing to work on a contractual basis
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
