Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 10 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad:
1. QUALITY ASSURANCE:
Designation : Dy. Manager / Asst. Manager / Sr. Executive / Executive
Qualification: M.Pharmacy / B.Pharmacy / M.Sc. (Life Science) / B.Tech / M.Tech (Biotechnology)
Job Roles :
: QA – In Process Drug Substance: Ensure that Bulk Vira Antigen production acheres to GMP standards on the shop floor, including line clearance, dispensing, and preparation processes. Examining and approving batch records, standard operating procedures (SOPs), project plans, customer verification (CV), and APS documents. QMS management requires the management of trends and batch releases, as well as the control and reconciliation of Master and Working Cell Banks.
Drug Product: Perform IPQ Fill-Finish tasks, which involve reviewing SOPs, batch records, executed validations, and media fills. Clearing lines for formula-tion, filling operations, and managing change controls, deviations, OOS investigations, and trend analysis.
QMS: Supervising QMS operations, including changes, deviations, OOS, 00T, CAPA, and self-inspection, as well as conducting compliance walkthroughs and Gemba walks. Responsibilities also include trending and reviewing QMS metrics, supporting regulatory inspection management, and managing the Site Master File, gap assessments, and quality risk assessments.
Training: Responsible for preparing, reviewing, and revising employee training processes to ensure that best practices are consistently updated and imple-mented. Skilled in speaking, reading, and writing Telug and English, and capable of conducting training sessions in Telugu. Responsible for providing the first GMP training for new recruits, including both employees and casual staff.
2. QUALITY CONTROL (BIOLOGICS/VACCINES):
Designation: Asst. Manager / Sr. Executive / Executive
Qualification: M.Sc. (Life Science) / B.Tech / M.Tech (Biotechnology)
Job Roles :
: Biochemical Assays: Involved in estimating the total and free components of polysaccharides, along with biochemical analyses such as protein, nucleic acid, aluminium content, and composition analysis. Experience in validating analytical methods, adhering to ALCOA principles, and managing OOS and OOT investi-gations.
Instrumentation Testing: Experience in handling analytical instruments such as HPLC and IC, as well as performing instrument-based assays including molecular size, aggregates, purity, and composition analysis, Basic troubleshooting, 21 CFR Part 11, audit trial review practices, ALA principles, 005, 001 systerns, and investigations.
Virology: Experience in in-vitro viral testing of starting materials, raw materials, in-process samples, final bulk samples, final lots, and stability samples for viral vaccines. Evaluate testing for the OC release of products, RM/stability studies of Viral Vaccines, and new projects/Products.
3. ENGINEERING (BIOLOGICS / INJECTABLES):
Designation
: Sr. Executive / Executive / Sr. Officer / Officer
Qualification: B.Tech / Diploma / ITI (Mechanical / Instrumentation / Fitter)
Required Skills: Instrumentation Maintenance: Experience in BMS, Breakdown maintenance, Preventive Maintenance, Calibration, SCADA, PLC.
Process Equipment: Experience in handling breakdowns and preventive maintenance of Vial Washing, Filling, Capping, Autoclave and Labelling Machines, Jacketed Vessels, lyophilization, and ability to handle shift operations.
Note :
Interested candidates are encouraged to walk-in with an updated Resume, latest increment letter, and payslips for the last 3 months on Saturday, April 19, 2025 from 09:30 am to 03:00 pm, at Hotel Sai Vishram, # 144-C/1, Kirloskar Road, Hebbagodi, Opp. MTR, Bommasandra Industrial Area, Bengaluru, Karnataka 560 099.
Candidates who are unable to attend the interview may send their CVs to [email protected]
PS: If an individual has already attended the interview in the past 6 months or has already been offered a position with us, please do not share the profiles.
