Biological E. Ltd Walk In Interview QA Dept

Biological E. Ltd Walk In Interview QA Dept 

Biological E. Limited (BE) invites experienced, dynamic, and self-motivated candidates with 2 to 12 years of experience for the following positions at its Vaccine Business in Shamirpet, Hyderabad:

Department : Quality Assurance :

1. Position : Executive/Sr. Executive / Asst. Manager/Deputy Manager

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

Required Skills: 

QA-Validation & CSV

•Validation, qualification and requalification of HVAC, process & packing equipment's, utilities etc.

•Preparation and review of URS, DQ, FAT, SAT & SOPs for computerised systems

•Preparation and review of the computerised systems qualification protocols (IQ/OQ/PQ), compilation of the executed protocols, and writing a report

•Prepare and review the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and identify the qualification and validation requirements

In Process QA (IPOA)

•Participation in media fill activities and process validation

•Reviewing log books and handling incidents in utility areas such as HVAC, water systems, and compressed air systems

•Handling investigations and changing controls

•Managing in-process checks in the filling and packing area

•Minimum three years of experience in a pharmaceutical GMP environment with aseptic practices (MHRA, FDA, WHO)

IT QA

•Ensure quality, compliance, and productivity by building validated IT applications, process control systems, and analytical systems

•Auditing computerized systems for 21 CFR Part 11, Annex 11, and GAMP requirements

•Supplier assessment, software classification, IT risk assessment, and mitigation strategy for manufacturing and testing applications

•GAP Assessment and Remediation procedures for new and legacy GxP systems are needed to ensure that the validation policy is in line with the Life Cycle Approach (GAMP 5)

•CSV schedule management includes backup, restore, archive, time synchronisation, and periodic evaluations

Walk In Interview Details

Date : Friday, October 18, 2024 

Time : 09:30 am to 02:00 pm 

Venue : Biological E. Limited, SEZ, Sy. No. 549-556, Genome Valley, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad - 500078, Telangana.

Note : 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

Biological E. Ltd Walk In Interview QA Dept