Walk in Drive in Quality Assurance at Biological E. Limited- October 25th,2024

About Biological E. Limited

Established during the Swadeshi Movement of India, Biological E. Limited (BE) emerged as a pioneering healthcare organization committed to ensuring access to essential medical products. Founded by Dr. DVK Raju, the company commenced operations in 1953, specializing in biological products such as liver extracts and anticoagulants.

With a focus on shifting from treatment to prevention, BE launched its Biotechnology Division (now the Vaccines and Biologics Division) and began large-scale production of DPT vaccines in 1962. Today, BE is a leading player in the vaccine manufacturing space and continues to innovate for better healthcare outcomes.

We are currently seeking experienced, dynamic, and self-motivated professionals with 3 to 8 years of experience for our Vaccine Business Unit in Shamirpet, Hyderabad.

Position:

Quality Assurance – Executive / Senior Executive

Location:

Shamirpet, Hyderabad

Qualifications:

• B. Pharmacy / M. Pharmacy / MSc (Life Sciences) / M. Tech (Life Sciences)

Key Responsibilities:

1. DS-IPQA (In-Process Quality Assurance):

• Overseeing cell or virus culture processes and performing bacterial line clearance activities.
• Drafting and reviewing SOPs, BPRs, MFRs, and related protocols.
• Managing deviations, change controls, and CAPA procedures effectively.
• Handling OOS/OOT investigations and reviewing analytical documents.
• Completing BPR reviews for batch release.
• Managing cell/viral banks and conducting process and cleaning validations.

2. QA – Validation & CSV (Computerized System Validation):

• Managing the validation, qualification, and requalification of equipment, utilities, and HVAC systems.
• Developing and reviewing URS, DO, FAT, SAT, and SOPs for computerized systems.
• Preparing and compiling reports for IQ/OQ/PQ protocols.
• Performing System Level Impact Assessments (SLIA) and ensuring compliance with 21 CFR Part 11 and EU Annex 11 guidelines.

3. Analytical Quality Assurance (AQA):

• Reviewing SOPs related to Quality Control and stability protocols.
• Investigating and closing OOS, OOT, and OOL reports.
• Monitoring and maintaining QC equipment logbooks and tracking deviations and CAPAs.
• Verifying protocols and analytical method validation reports.
• Confirming Media Fill vial records and reviewing EMP, water trends, and material testing SOPs.

Interview Details:

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

What to Bring:

• Updated CV
• Latest increment letter
• Last 3 months’ payslips
• Educational and relevant certificates

Additional Information:

• If you have attended an interview with us in the past 6 months or received an offer, please do not reapply.
• Candidates unable to attend may send their CVs to careers@biologicale.com.