Biological E Ltd Walk In Interview For Quality Assurance Dept

 Biological E Ltd Walk In Interview For Quality Assurance Dept

Position : Executive/Sr. Executive

Qualification: B.Pharmacy/M. Pharmacy / M. Sc. (Life Science) / M. Tech. (Life Science)

Experience:  3 to 8 years 

Required Skills:

 1) 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

2)QA-VALIDATION & CSV:

• 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

3) 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 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.