Biological E Walk In Interview For Quality Control and Quality Assurance Dept

Biological E Walk In Interview For Quality Control and Quality Assurance Dept 

Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 10 years of experience for the below positions at its Vaccine Plant, Shamirpet, Hyderabad:

1) 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: To execute Bulk Viral Antigens IPQA activities, including 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 computerized systems and equipment. Preparation and review of URS, DQ, FAT, SAT, & SOPs for computerized systems documentation. The process of preparing / reviewing the Computerized Systems Qualification Protocols (IQ/OQ/PQ), compiling the executed protocol, and writing a report. Verification of 21 CFR part 11 compliance and periodic evaluation of GxP systems.

2) 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 filling and finishing activities for IPQA. Reviewing SOPs, Batch Records, validating and filling media, and clearing lines for formulation and filling activities. Management of change controls, deviation, OOS, and trends.

QMS: Supervising QMS operations such as change control, deviation, OOS, OOT, CAPA, self-administrated compliance walkthroughs, Gemba Walks, Trending and review of QMS metrics, and aiding in regulatory inspection management. Management of site master files, gap, and quality risk assessments.

QA-VALIDATION: Execution of periodic qualifications for Facility, Utilities, and Equipment, documentation management for validation activities, periodic walkthroughs of technical areas, review of calibration, PM, and EM records.

3) 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, OOS, 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, April 28, 2024 from 09:00 am to 03:00 pm at Hotel Lemon Tree, Phase 1, Rajiv Gandhi Infotech Park, Hinjawadi, Pimpri-Chinchwad, Pune, Maharashtra 411057.

Biological E Walk In Interview For Quality Control and Quality Assurance Dept