Biological E. Ltd Released Job Openings On 29/06/2022.Biological E limited is a privately held biopharmaceutical company based in Hotel Cygnett Lite, VIZAG., Telangana, India. It specialises in the areas of low-cost vaccine Supervisor/Sr.Officer/Officer/Executive /Technician /Sr.Technician.
Vacancy Details:
Biological E. Ltd Recruiting M.Sc , M.Pharma, M.Tech Graduates with 5-9+ years Experience for Senior Executive /Assistant Manager -CM Quality Position.
Important Details :
- Location :Shamirpet, Hyderabad
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 29/06/2022
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- To Support the formulation activities in DQA at Contract Development Organization and Contract Manufacturing organization (CDMO).
- Review of the Formulation development documents along with all supporting raw data.
- Development Strategy Note
- Process optimization Study protocols
- Filter Validation
- Stability & Photo stability protocols of R&D batches, Scale-Up and Exhibit batches
- Scale-up batch documents
- Diluent compatibility study protocols
- In-Use stability study protocols
- Review of Pharmaceutical Development Report
- Review of Technology Transfer Dossier (TTD) for accuracy and compliance to laid down procedures and issuance of TTD to CMO as per agreed timelines.
- Preparation of DQA (CDMO) Guidelines/ SOPS.
- Monitoring of Tech transfer, Validation Batches, Stability Samples, Control Samples at CMO sites.
- Providing CMC documents to Regulatory for appropriate ANDA filings.
- Check for COAs and backup data for the entire test carried out at CMO site.
- Review of Exhibit Batch Manufacturing documents.
- Review of FRD & PRD Specifications and STP (Excipients, Drug substances, Drug products) during development stage.
- Ensuring the CGMP compliance at CMO sites.
- Review of executed Batch Manufacturing Records before Batch release.
- Preparation of Audit reports.
- Evaluation of vendor qualification documents
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