Established in 1953, Biological E. Limited (BE) is a leading, world-class Pharmaceutical and Biologics company with an impressive range of healthcare products. We are a company driven by knowledge – a huge pool of talent that gives us the competitive advantage to make an impact in the global markets.
DATE AND TIME:
- Date: Saturday, December 07, 2024
- Time: 09:30 am to 02:00 pm
- Venue: Biological E. Limited, Aditya Enclave, Venkatagiri, Road No. 35, Jubilee Hills, Hyderabad, Telangana 500033.
Candidates who are unable to attend the interview may send in their CVs at Careers@Biologicale.com
ENGINEERING (Injectables):
- Position: Officer/Sr. Officer
- Qualification : Diploma/ITI (Mechanical / Instrumentation/Fitter)/B.Tech (Mechatronics Engineering also is preferred)
Required Skills:
HVAC & UTILITIES:
- Maintenance of Cold Rooms, Walk-in Incubators, Deep Freezers, LAFU’s, DPB’s, GC’s, Bio Safety Cabinets, Industrial Refrigerators, LSSUs, Chillers, and Hot Water Generation Systems
- Preventive maintenance of cold rooms and walk-in incubators (cold and hot)
- BMS and EMS operations, including alarm handling with GMP documentation
- Preventive maintenance and operation of HVAC Chillers, AHUS, OAUS, VAUS, EFFs, and RCUs
- Carry out preventive maintenance while simultaneously updating log books and GCRs
- Attend breakdowns and carry out preventive and corrective maintenance tasks
MECHANICAL MAINTENANCE:
- Should have experience in breakdowns and preventive maintenance of Vial Washing, Filling, Capping, Autoclave and Labelling Machines, Jacketed Vessels, and Lyophilization
- Skilled in managing shift operations of process equipment such as Bio Reactors, WFI Coolers, Centrifuge, Autoclaves, Glassware Washers, Media and Pooling Vessels, TFF, -70 Deep Freezers, CIP/SIP Systems, Bio Safety Cabinets, Sealers, Blending Equipment, Autoclaves, Vail Packing Lines, Auto Cartoning, Optical Testing Machine, and CIP/SIP Systems.
INSTRUMENTATION MAINTENANCE:
- Skilled in handling shift operations for instrumentation activities such as BMS, Breakdown Maintenance, Preventive Maintenance, Calibration, AMC, and interim projects. Reviewing the completion of breakdown status, calibration, and PM works.
- Handling basic troubleshooting in Programmable Logic Controllers (PLC) and Supervisory Control & Data Acquisition (SCADA)
QUALITY ASSURANCE:
- Position Executive/Sr. Executive/Asst. Manager
- Qualification: B. Pharmacy/M. Pharmacy/M.Sc. (Life Science)/M. Tech. (Life Science)
Required Skills:
DRUG SUBSTANCE-IPQA (IN PROCESS)
- A Hands-on experience in Cell/Vinas Culture Process/Bacterial/Line Clearance Activities, preparation of SOP/BPR/MFR/protocols and review, deviation, change control handling, and knowledge on investigational tools and CAPA management. Hands on experience in 005/00T handling and analytical document review. Familliarity with the cell/viral bank system and maintenance
DRUG PRODUCT-IPQA (IN PROCESS):
- Participating in media fill activities and validating the process
- Reviewing log books and handling incidents in utility areas such as HVAC, water systems, and compressed air systems Handling investigations, change controls, and in-process checks in the filling and packing area It is recommended that you have at least three years of experience in a Pharmaceutical GMP environment with aseptic practices (MHRA, FDA, WHO) Examine batch production records and log books of blending and filling
QA-VALIDATION & CSV:
- The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
- Creating and examining URS, DO, FAT, SAT & SOPs for computerized systems, and analyzing the 10/00/PQ Computerized Systems Qualification protocols Compiling the executed protocol and writing a report.
- Reviewing the System Level Impact Assessment (SUA), 21 CFR Part 11, EU Annexure 11, checklist, and identifying the qualification and validation requirements.
- QA-QMS
- Responsible for handling internal audit, walkthrough, and quality risk assessment systems
- Trending in change control and deviations
- Organize and evaluate the monthly, quarterly, half-yearly, and annual trends of change controls and deviations
- Quality Matrix and other QMS-activities
- Preparation of an audit tracker and periodic review schedule tracker for vendors, Implementing various CAPAs to improve quality systems
- Evaluating changes made through Change Controls by Inter-Departmental Functionalities through assessment, categorizing, and evaluation
REGULATORY AFFAIRS (Vaccine):
Position: Asst./Deputy Manager/Senior Executive
Required Skills:
- The candidate should have experience in India, World Health Organization, and Row
- Preparation and review of regulatory submission packages related to Indian NRA, such as post-approval change and marketing authorization applications. Assisting in responding to queries for various regulatory authorities
- The preparation of dossiers/submission packages for NRA submissions, as well as dossiers for registration in ROW countries. The Documentation database that is available with RA is kept up-to-date. Collaborating with cross-functional departments such as QA, QC, Production, Warehouse, Distribution and Marketing, and Product Lifecycle management
- Regular interaction with QA documentation for updating master files Review of pack profiles and artwork (labels and package imerts).
- Recombinant Products require approval from RCGM/GEAC
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