Biocon Biologics Released Job Openings On 03-11-2021.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.

Vacancy Details:

Biocon Biologics Recruiting M.sc,B.tech,B.com Candidates with 01 – 18 Years of Experience for EXECUTIVE/SENIOR EXECUTIVE/ASSOCIATE MANAGER/SENIOR SCIENTIST Position.Complete Details for the EXECUTIVE/SENIOR EXECUTIVE/ASSOCIATE MANAGER/SENIOR SCIENTIST 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: 03-11-2021
• 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

Biocon Biologics Limited Hiring For EXECUTIVE/SENIOR EXECUTIVE/ASSOCIATE MANAGER/SENIOR SCIENTIST.

ASSOCIATE MANAGER

• Provide SAS programming support to all clinical projects (Phase 1 to 4). Manage programming CROs providing oversight for programming deliverables. Create programming related SOPs, as necessary. Works in tandem with CRO’ s Biostatistics and SAS Programming and Data Management teams on various clinical projects.
• Provide statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for integrated reports).
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming. Applying your SAS programming skills, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s). Generating complex ad-hoc reports for publications.
• Reviews/Develops SAS macros, templates and utilities for data cleaning and reporting. Reviews/ analyses specified in the protocol or the Statistical Analysis Plan (SAP) is implemented while working with the biostatisticians.
• Reviews CRF annotations and data specifications & discuss data structures and participate in data review activities.

EXECUTIVE

1. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
2. Qualification of Analytical instruments and Equipments (IQ/OQ/PQ) and Facility readiness.
3. Receipt of inprocess, DS, reserve samples and stability samples and storage at QC location.
4. Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies and reporting the results.
5. Review of analytical reports of Inprocess, finished product, stability, method validation, method transfer and study, Review of usage log books and Observation data sheets.
6. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
7. Planning and performing (Testing) of method transfer, method validation and study samples.
8. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
9. Reporting and investigation of Incidents, OOS, OOT and Deviation.
10. Supporting Operational Excellence, 5S in Quality control Lab.
11. Calibration of analytical weighing balance, HPLC, UV, IR, and pH meter etc.
12. Ensure & Implementation of Data Integrity Culture in Quality Control Lab.

SENIOR EXECUTIVE

1. Preventive maintenance, Break down maintenance for packing equipment’s and Utilities
2. Updating preventive maintenance checklists, history records.
3. Planning and procurement of spare parts for the Packing section.
4. Shift handling and equipment operations.
5. Energy Management in the area.

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