Biological E – Interview For Quality Assurance and Quality Control Dept on March 3, 2024
BE Biological E. Limited
with 2 to 10 years of experience for the below positions at its Vaccine Plant, Shamirpet, Hyderabad:
QUALITY ASSURANCE (Drug Substance):
1. Position : Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification:M.Sc. (Life Sciences) / B.Tech/M.Tech (Biotechnology)
Required Skills:
INPROCESS QA: Handle 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 the master/working cell bank. Review/compilation of BPRs, testing reports, and EMP data. CSV: Manage the validation and qualification activities of computerized systems and equipment. Preparation and review of URS, DQ, FAT, SAT, and SOPs for Computerized Systems documentation. Preparation and review of computerized system qualification protocols (10/00/PQ), compilation of the executed protocols, and writing reports. Compliance verification for 21 CFR part 11, EU Annexure 11, and periodic evaluation of GxP systems.
QUALITY ASSURANCE (Drug Product):
1. Position Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification M. Pharmacy / B. Pharmacy/ M.Sc. (Life Sciences) / B.Tech/M.Tech (Biotechnology)
:
Required Skills:
INPROCESS QA: Responsible for fill finish activities in IPQA. Review of SOPs, Batch Records, executed validation and media fills, and clearance of lines for formulation and filling activities. Management of change controls, deviations, 005, and trends.
QMS: Supervision of QMS activities including change control, deviation, 005, 0OT, CAPA, self-assessment, compliance walkthroughs, Gemba Walks, trending and review of QMS metrics, and assistance with managing regulatory inspections. Management of site master file, gaps, and quality risk assessments.
QA-Validation: Execution of periodic qualifications for Facility, Utilities, and Equipments, documentation management for validation activities, periodic walkthroughs of technical areas, review of calibration, PM, and EM records.
QUALITY CONTROL (Biologics/Vaccines):
1. Position : Dy. Manager/Asst. Manager/Sr. Executive/Executive
Qualification M.Sc. (Life Sciences) / B.Tech/M.Tech (Biotechnology)
Required Skills:
BIOCHEMICAL ASSAYS: Estimation of Total & Free Component in Polysaccharides, Biochemical analysis such as Protein, Nucleic acid, Aluminium, Composition analysis, Technology Transfer and Analytical Method Validation, ALCOA principles, document reviews, 005, OOT systems and investigations, QMS elements such as Change control, Deviations, CAPA management and Audit exposure. INSTRUMENTATION TESTING: Hands-on experience in handling instruments such as HPLC, IC, and instrument-based assays such as mol Size, Aggregates, Purity, Composition analysis, Basic troubleshooting, 21 CFR Part 11 and Audit trial review practices, Technology transfer and Analytical method validation, ALCOA principles, document reviews, 005, OOT systems and investigations, QMS elements such as Change control, Deviations, CAPA management & Audit exposure.
Interested candidates may Walk-in with an updated resume, certificates, latest increment letter and last 3 months’ pay slips on Sunday, March 3, 2024 from 09:00 am to 03:00 pm at Hotel Sai Vishram,
#144-C/1, Kirloskar Road, Hebbagodi, Opp. MTR, Bommasandra Industrial Area, Bengaluru, Karnataka 560099.
PS: Candidates who are unable to attend in person may send in their CVs with the subject line ‘Applying for Department Name” to careers@biologicale.com” Please refrain from sharing profiles of individuals who have already attended an interview or been offered a position with us within the last 6 months.
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