Walk in Drive in Quality Assurance at Biological E. Limited-18th Oct’ 2024

Pharmaceuticalcarrier; Hyderabad; On-site; INR 5,00,000 - 8,00,000; Full time

Job summary

A leading pharmaceutical company in Hyderabad is hiring for roles like Executive/Senior Executive in their Vaccine Business. Candidates should have relevant experience in validation, quality assurance, and IT operational assurance. Key responsibilities include executing validation protocols and ensuring compliance with regulatory standards. The company offers a walk-in interview opportunity on October 18, 2024. Apply now to contribute to innovative vaccine solutions.

Qualifications

• Minimum 2 to 12 years of relevant experience in a pharmaceutical environment.
• Proficiency in executing validation and qualification protocols.
• Strong understanding of GMP standards and regulatory compliance.

Responsibilities

• Execute validation and qualification of HVAC, utilities, and process equipment.
• Participate in media fill activities and process validations.
• Build and validate IT applications for quality compliance.

Skills

Qualification and validation protocols for pharmaceutical systems

GMP practices and regulatory standards

21 CFR Part 11 compliance

Aseptic pharmaceutical environments

Education

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

Job description

About 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 [e-mail].

Join us at Biological E. Limited and be part of our mission to build a healthier future through innovative vaccine solutions!