Biological E. Limited Celebrating Life Every Day,Biological E. Limited invites experienced, dynamic and self-motivated candidates with 3 to 8 years of experience for the below positions at its Vaccine Plant, Shamirpet, Hyderabad
Job description:
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 00S/00T 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
0A – 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 10/0Q/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.
0A – 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
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
Walk in interview Details:
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 on Saturday, December 07, 2024
from 09:30 am to 02:00 pm at Biological E. Limited, Aditya Enclave, Venkatagiri, Road No. 35,
Jubilee Hills, Hyderabad, Telangana 500033.
PS: If you have already attended the interview in the past 6 months or if we have already offered you a position, please do not attend.
Candidates who are unable to attend the interview may send in their CVs at [email protected]
