Biological E. Limited, the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. BE is also the first pharmaceutical company in South India. Ever since its inception, the focus is on providing affordable access to quality healthcare. The branded formulation business has consistently remained as a strong pillar for the organization.
Biological E. Limited (BE) invites experienced, dynamic, and self-motivated candidates with 3 to 8 years of experience for the following positions at its Vaccine Business in Shameerpet, Hyderabad:
QUALITY ASSURANCE:
- Position: Executive / Sr. Executive
- Qualification: B. Pharmacy / M. Pharmacy / M. Sc. (Life Science) / M. Tech. (Life Science)
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Required Skills:
DS-IPQA (IN PROCESS):
- Handling cell or virus culture processes, including bacterial line clearance activities
- Preparation of SOPs, BPRs, MFRs, and protocols for review Deviation, change control handling, and knowledge of investigational tools and CAPA management
- OOS/OOT handling and knowledge on analytical document review
- Completed the BPR review and batch release
- Maintenance of the cell/viral bank system
- Validating cleaning and processes
- The validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
- Creating and evaluating URS, DQ, FAT, SAT & SOPs for computerized systems
- Writing a report after preparing and reviewing the Computerized Systems Qualification protocols (IQ/OQ/PQ), compiling the executed protocols.
- Generate and evaluate the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and determine the qualifications and validation demands
ANALYTICAL QUALITY ASSURANCE (AQA):
- Review of SOPs pertaining to Quality Control and stability protocols
- Responsible for investigating and closing Out of Limit (OOL), Out of Trend (OOT), and Out of Specifications (005)
- Examine the equipment log books for QC
- Follow up on the closure of deviations, change controls, and CAPAs related to the QC area.
- Keeping track of OOS, OOT, and OOLs and updating the relevant databases and logbooks.
- Evaluate the protocols, RORs, and reports to verify analytical methods and other studies.
- Confirmation of Media Fill vials
- Review of EMP, water trends, specifications, and testing SOPs for materials/products
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: Friday, October 25, 2024
- Time: 09:00 am to 02:30 pm
- Venue: Biological E. Limited, Shankarpalli Road, Patancheru Industrial Area. Patancheru, Hyderabad, Telangana – 502319.
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 Careers@Biologicale.com
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