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:
Walk-in-Interview
QUALITY ASSURANCE:
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):
•Hands-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 OOS/OOT 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.
QA – 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 IQ/OQ/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.
QA – QMS:
•Responsible 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):
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.
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
Date: Saturday, December 07, 2024
Time: 09:30 am to 02:00 pm
Venue:
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]
