Biological E Limited Walk-In Interview On 28th Apr In Pune | QA & QC ( Vaccine Business)
Walk-In Interview On 28th Apr In Pune | QA & QC ( Vaccine Business)
Walk-in Interview on 28th Apr’24 in PUNE
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:
Quality Assurance (Drug Substance)
Designation: Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification: M.Sc. (Lifesciences) / B. Tech/M. Tech (Biotechnology)
Job Roles:
INPROCESS QA: To execute for Bulk Viral Antigens IPQA activities which includes GMP compliance on shop floor, line clearance, Dispensing, Preparation, review and approval of Batch Records, SOPs, PV, CV and APS documents, QMS Management, Trending and Batch release activities. Control and reconciliation of Master/ Working cell bank. Review/compilation of BPRs, testing reports and EMP data.
CSV: To manage the validation and qualification activities of the computerized systems and equipments. Preparation and review of URS, DQ, FAT, SAT, & SOPs of Computerized Systems documentation. Preparation / Review of the Computerized systems Qualification protocols (IQ/OQ/PQ), compilation of the executed protocol and writing report. 21 CFR part 11, EU Annexure 11 compliance verification, Periodic evaluation of GxP systems.
Quality Assurance (Drug Product)
Designation: Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification: M. Pharmacy/ B. Pharmacy/ M.Sc. (Lifesciences) / B. Tech/M. Tech (Biotechnology)
Job Roles:
INPROCESS QA: Responsible for IPQA Fill Finish activities. Review of SOPs, Batch Records, executed validation and media fills, Line clearance for formulation and filling activities. Change controls, deviation, OOS and Trending management.
QMS: Oversight on QMS activities like change control, deviation, OOS, OOT, CAPA, self and, performing Compliance walkthroughs and Gemba Walks, Trending and review of QMS metrics, support for regulatory inspection management. Management of Site master file, Gap and Quality risk assessments.
QA Validation: Execution of periodic qualifications for Facility, Utilities and Equipment, documentation management for validation activities, periodic walk throughs of technical areas, Review of calibration, PM and EM records.
Quality Control (Biologics/Vaccines)
Designation: Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification: M.Sc. (Lifesciences) / B. Tech/M. Tech (Biotechnology)
Job Roles:
Biochemical Assays: – Estimation of Total & Free component in polysaccharides, Biochemical analysis like Protein, Nucleic acid, Aluminium, Composition analysis, Technology transfer and Analytical method validation, ALCOA principles, document reviews, OOS, OOT systems and investigations, QMS elements like Change control, Deviations, CAPA management and Audit exposure.
Instrumentation Testing: – Hands on experience in instruments handling like HPLC, IC, Instrument based assays like Mol. Size, Aggregates, Purity, Composition analysis, Basic trouble shootings, 21 CFR Part 11 and Audit trial review practices, Technology transfer and Analytical method validation, ALCOA principles, document reviews, OOS, OOT systems and investigations, QMS elements like Change control, Deviations, CAPA management & Audit exposure.
Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months payslips on 28th April, 2024 i.e., Sunday from 09:00 am to 03:00 pm at Hotel Lemon Tree, Phase 1, Rajiv Gandhi Infotech Park, Hinjawadi, Pimpri-Chinchwad, Pune, Maharashtra 411057.
PS: Candidates who are unable to walk-in may send in their CVs by mention subject as Applying for Department Name to [email protected].
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.
– Human Resources
– Corporate Communications
Time and venue:
28th Apr, 9.30 AM – 3.00 PM
Hotel Lemon Tree, Phase 1, Rajiv Gandhi Infotech Park, Hinjawadi, Pimpri-Chinchwad, Pune, Maharashtra 411057.
Contact – HR
