Job Summary

1. Preparation of various master documents required for the submission batch execution and supports the product development by preparation of documents like master production records, Master Packing records and various reports like Exhibit Batch Summary Reports, Hold Study reports, Photo stability Reports, Transportation worthiness study report, Bulk product Stability Reports, SOPs and other miscellaneous reports.
2. Responsible for Maintenance & updating of proper inventory of all the change parts and accessories for the equipments and Instruments.
3. Indenting the punches, dies & machine change parts for the development and submission batches. Issuance of Logbooks for the new equipments, instruments, punches and dies.
4. Preparation of Purchase indents in SAP for the procurement of raw and packing materials.
5. Supporting the other sub-ordinates in learning of the equipments, system and process.
6. Perform all work in accordance with established regulatory, compliance and safety requirements.
7.



Works in a safe manner collaborating as a team member to achieve all outcomes.
8. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
9. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Workplace policies, and HR policies.
10. All other relevant duties as assigned related to Docuemntation & change controls

Job Responsibilities
- To prepare various documents like SOP s, Formats, protocols, Reports, Master formulas, SMM, SPM etc., for the Formulation Development Laboratory.
- To maintain and safeguard the equipment and other properties of company that is assigned for the purpose of use in processes.
- To maintain the safety and housekeeping practices at work place.
- Practice and up-gradation of knowledge with respect to cGMP.
- To maintain online documents for the activities carrie

📌 Senior Executive (Bengaluru)
🏢 Apotex
📍 Bengaluru