Biocon Biologics Released Job Openings On 21/12/2021.Biocon Biologics is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.
Biocon Biologics Recruiting B.sc,B.tech Candidates with 02 – 15 Years of Experience for MANAGER/SENIOR ANALYST/SENIOR DIRECTOR/ASSISTANT MANAGER/JUNIOR EXECUTIVE/SENIOR EXECUTIVE/EXECUTIVE/DEPUTY MANAGER Position.Complete Details for the MANAGER/SENIOR ANALYST/SENIOR DIRECTOR/ASSISTANT MANAGER/JUNIOR EXECUTIVE/SENIOR EXECUTIVE/EXECUTIVE/DEPUTY MANAGER as follows.
Important Details :
- Location :India
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 21/12/2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
Downstream operation team member in mammalian manufacturing facility with 3+ years experience
1) Shall be able to handle shift activity and instrumentation breakdowns and PLC PM, Time synchronization, Alarm Verification.
2) Shall have the knowledge of Basic instrument trouble shooting knowledge (Pressure transmitter, Temperature Transmitter, Flow Transmitter, Conductivity transmitter, ORP sensor, PH sensor, Level sensors) Loop testing.
3) Shall have sterile equipment handling work experience ( Autoclave , Filling Line , Lyophilizer, HVAC, Water system, BMS, DCS, Online /Offline PMS Data logger, Integrity testing machine )
4) Shall have basic knowledge of instrument calibration.
5) Shall have knowledge of preparation of cGMP document ( SOP, Protocols , Planners, Change control , Deviation )
6) He should willing to work in the shifts.
7) Shall have 3-4 years working in the process and Pharma industry experience.
- Handling of MRM (Management Review Meeting)
- Handling of Audit management with Regulators and Customers
- Handling of Internal audit management.
- Handling of QC raw material management and Warehouse functions
- Review of Out of specifications, Deviations, Laboratory incidents, Change controls and CAPA.
- Handling of Document control and SOPS procedures at QA
- Track wise exposure on QMS documents
- Support vendor qualification activity.
- Coordination with QA teams for support of QMS activities.
- Review of Supplier Qualification documents and support to CQA.
• Analyse product specifications and applicable regulations /legislations for the programme
• Provide inputs on material choice proposed to meet performance requirements of the product
• Support the creation and maintenance of manufacturing process documentation
• Support the Design team with regard to specifications knowledge and product robustness
• Participate in design reviews and DFMEA processes
• Work closely with suppliers to determine manufacturing parameter
• Lead activities such as Mold Flow analysis, tool validation, FAT measurement etc. to ensure product /components meet the specifications
• Participate in the product validation activities
• Interfacing with internal and external team to deliver updates, design recommendations and manufacturing analysis results
• Preparation of detailed technical presentations for project engineering review
• Support in reaching the quality, costs and delivery targets of the program
• Support design review and contribute to achievement of Engineering Milestones and contribute to continuous improvement activities
• Support and lead process improvement activities
• Execute the verification and validation activities for drug delivery systems.
• Participate and provide inputs for resource planning, scheduling and overall execution of verification and validation activities
• Responsible for verifying product attributes for each development life cycle phase
• Set-up of testing infrastructure, test benches, jigs and fixtures for testing of electro-mechanical drug delivery systems.
• Work closely with different systems engineering & sub-systems team (mechanical & electronics) to understand overall system level architecture, interaction between different sub-systems, identify critical safety and quality characteristics to develop test plan & protocols
• Plan and execute verification of prototypes, pilot batch, feasibility runs for drug delivery systems
• Work closely with manufacturing, quality control and assurance teams to develop consistent test methodologies, transfer to test specifications and adopt best practices for verification and validation activities