- Full Time
- Shamirpet, Hyderabad
Website Biological E. Limited
Table of Contents
ToggleAbout Biological E. Limited
Established during the Swadeshi Movement of India, Biological E. Limited (BE) was founded by Dr. DVK Raju in 1953 to address the nation’s need for essential healthcare products. Initially focused on producing liver extracts and anti-coagulants, BE transitioned into vaccines and biologics in 1962, becoming one of the earliest producers of DPT vaccines in India. With a mission to prevent diseases through innovation, BE has grown into a leading pharmaceutical company, headquartered in Hyderabad.
We are seeking experienced, motivated, and skilled professionals with 2 to 12 years of relevant experience to join our Vaccine Business at our Shamirpet, Hyderabad facility.
Current Openings
Position:
- Executive / Senior Executive / Assistant Manager / Deputy Manager
Location:
- Biological E. Limited, Shamirpet, Hyderabad
Qualifications:
- B. Pharmacy / M. Pharmacy / MSc (Life Sciences) / M. Tech (Life Sciences)
Roles & Key Responsibilities:
Validation & CSV (Computer System Validation)
- Execute validation, qualification, and requalification of HVAC, utilities, and process/packing equipment.
- Prepare and review URS, DQ, FAT, SAT, and SOPs for computerized systems.
- Develop and compile qualification protocols (IQ/OQ/PQ) and completion reports.
- Conduct System Level Impact Assessments (SLIA) and ensure compliance with 21 CFR Part 11 and EU Annex 11 guidelines.
In-Process QA (IPQA)
- Participate in media fill activities and process validations.
- Monitor utility systems such as HVAC, water, and compressed air systems; handle incident reporting.
- Investigate and manage change controls as per GMP standards.
- Perform in-process quality checks within filling and packaging areas, ensuring compliance with MHRA, FDA, and WHO standards.
IT Operational Assurance (IT OA)
- Build and validate IT applications, control systems, and analytical tools for quality compliance.
- Conduct audits for computerized systems, aligning with GAMP 5 guidelines and 21 CFR Part 11 requirements.
- Perform supplier assessments, software classification, and IT risk mitigation.
- Manage CSV schedules for backup, restore, archive, time synchronization, and system evaluations.
Required Skills:
- Proficiency in qualification and validation protocols for pharmaceutical systems.
- Strong knowledge of GMP practices and regulatory standards.
- Experience with 21 CFR Part 11, GAMP 5, and EU Annex 11 compliance.
- A background in aseptic pharmaceutical environments.
Walk-In Interview Details:
Date: Friday, October 18, 2024
Time: 09:30 AM – 02:00 PM
Venue:
Biological E. Limited, SEZ, Sy. No. 549-556, Genome Valley, Kolthur Village, Shamirpet Mandal,
Medchal-Malkajgiri District, Hyderabad – 500078, Telangana
What to Bring:
- Updated CV
- Latest increment letter
- Last 3 months’ payslips
- Educational certificates and other relevant documents
Additional Information:
- If you have attended an interview with us in the last six months or have already received an offer, kindly refrain from attending.
- Candidates unable to attend the walk-in interview can email their CV to careers@biologicale.com.
Join us at Biological E. Limited and be part of our mission to build a healthier future through innovative vaccine solutions!
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To apply for this job email your details to careers@biologicale.com