Biological E Limited Life Sciences Quality Assurance Positions Available Now!
Walk-in-Interview
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 Shamirpet, Hyderabad:
Quality Assurance
Position: Executive/Sr. Executive
Qualification: B. Pharmacy/ M. Pharmacy / M. Sc. (Life Science) / M.Tech. (Life Science)
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 of analytical document review.
- Completed BPR review and batch release.
- Maintenance of the cell/viral bank system.
- Validating cleaning and processes.
QA – Validation & CSV:
- Validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
- Creating and evaluating URS, DO, FAT, SAT & SOPs for computerized systems.
- Writing and reviewing Computerized Systems Qualification protocols (IQ/OQ/PQ), compiling executed protocols.
- Generating and evaluating the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and determining 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 (OOS).
- Examining equipment log books for QC.
- Following 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.
- Evaluating protocols, RORS, and reports to verify analytical methods and other studies.
- Confirmation of Media Fill vials.
- Reviewing EMP, water trends, specifications, and testing SOPs for materials/products.
Application Instructions:
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 on Friday, October 25, 2024, from 09:00 am to 02:30 pm at 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 [email protected]
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