- Johor Bahru, Johor Johor Bahru Johor Malaysia
Working Location
Job Description
Responsibilities
Roles and Responsibilities
1. To execute the process operations and monitor the batch performance as per standard procedures in the plant
2.To practice and monitor the compliance with the requirements of Good Manufacturing
3. To execute the instructions relating to production operations
4. Follow the established procedures and policies of the company pertaining to EHS management system and compliance.
5. To update the BMRs and other production records at real time
6. Maintenance and utilization of raw materials as per production requirement
7. Reporting of Non-Conformities and deviation observed during the process, investigating, arriving corrective and preventive action and ensuring the implementation of the same.
8. To ensure timely maintenance of PDS Upstream premises and equipments in co-ordination with Engineering Maintenance and Instrumentation and Automation department.
9. To follow timely and effective communication and report process and facility related issues to appropriate higher levels
10. To execute Qualification and Validation protocols as per plan
11. To participate in Commissioning and Qualification activities
12. To prepare and revise necessary documents as and when required
13. Responsible for Process order and Inventory management in SAP system.
14. Raw material planning for the batch and procurement from the warehouse, maintenance and utilization as per production requirement.
15. Managing and closure of OOS, change management and deviation.
16. Data owner for process equipment used in day-to-day activity
Required Skills & Competencies
Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.
4 - 11 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
About The Benefits
At Biocon, you’ll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.
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