Biological E. Limited Walk In Interview For Engineering/ QA/ RA Dept
1) ENGINEERING (Injectables):
1. 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)
2) QUALITY ASSURANCE:
1. 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):
AHands-on experience in Cell/Virus 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 OOS/OOT handling and analytical document review. Familiarity 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, DQ, FAT, SAT & SOPs for computerized systems, and analyzing the IQ/00/PQ Computerized Systems Qualification protocols
Compiling the executed protocols and writing a report. Reviewing the System Level Impact Assessment (SLIA), 21 CFR Part 11,
EU Annexure 11, checklist, and identifying the qualification and validation requirements.
QA-QMS:
TResponsible 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
3) REGULATORY AFFAIRS (Vaccine):
1. 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 inserts). Recombinant Products require approval from RCGM/GEAC
Note : Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months' payslips, along with education and other relevant documents
Walk In Interview Details
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.
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Biological E. Limited Walk In Interview For Engineering/ QA/ RA Dept |
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