Walk In Drive at Goa -QA/Production/Engineering/Antigen Manufacturing

Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 8 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad.

PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS)

Designation: Sr. Executive/Executive/Sr. Officer/Officer

Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI

Desired Experience: Applicants with relevant experience in Vaccine, Biosimilars or Injectable Manufacturing will be considered.

• To perform Upstream and Downstream activities of bacterial or Viral antigens
• Execution of upstream and Downstream production batches. Focus on timely execution, to ensure that the process is carried out as per cGMP compliance and batch timelines
• Execution of documentation activities of liaison with QA and QC as per cGMP compliance.

PRODUCTION FORMULATIONS (Injectables / Vaccines)

Designation: Sr. Executive/Executive/Sr. Officer/Officer

Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI

BLENDING:

Ability to handle shift plans for formulation activities. Operate and maintain equipment like autoclave, blending vessels. Ability to handle and maintain equipment like autoclave, blending vessels, CIP and SIP skids.

FILLING:

Ability to handle shift plans for filling activities. Operate and maintain equipment like Vial washing, Tunnel Sterilizer, Filling and Capping.

PACKING & LABELLING:

Ability to handle shift plans for Vial labelling Machine & VVM dot Machines with Inspection system. Operation of Videojet and Control print Printer for Batch Coding. Operation of Track & Trace System, monitoring of Cold room and Deep freezers temperatures.

Engineering (Biologics/Injectables):

Designation: Sr. Executive/ Executive/Sr. Officer/Officer

Qualification: B Tech / Diploma

Process Equipment’s:

Experience in Breakdowns and preventive maintenance of Vial Washing, Filling, Capping, Autoclave and Labelling Machines, Jacketed Vessels, lyophilization, Ability to handle shift operations.

Instrumentation:

Ability to handle shift operations for Instrumentation activities like BMS, Breakdown maintenance, Preventive Maintenance, Calibration, AMC and Interim projects, Reviewing the completion of breakdown status / Calibration / PM works, Handling basic troubleshooting in PLC (Programmable Logic Controllers) and SCADA (Supervisory Control & Data Acquisition).

QA

Designation : Sr. Executive/Executive

Qualification : M. Pharmacy/M.Sc./ B. Pharmacy

AQA

Review of SOPs pertaining to Quality Control, stability protocols.

Responsible for investigation and closure of OOL, OOT & OOS.

To review the Equipment log books of QC.

Follow up for the closure of deviations/ change controls/CAPAs pertaining to QC area.

To log OOS, OOT and OOLs and update the relevant databases and logbooks

To review the analytical method validation/other study Protocols, ROR and Reports

Verification of Media Fill vials.

Review of EMP, Water trends, specifications and testing SOPs of materials/ Product.

To prepare, review of the Quality Risk assessment documents.

QMS:

Oversight of QMS activities, including change control, deviations, OOS, OOT, CAPA, and self-inspections, as well as conducting compliance walkthroughs and Gemba walks. Responsibilities also include trending and review of QMS metrics, support for regulatory inspection management, and the management of the Site Master File, gap assessments, and quality risk assessments.

IPQA - Drug Substance:

To execute IPQA activities for Bulk Viral Antigen production, including ensuring GMP compliance on the shop floor, line clearance, dispensing, and preparation processes. review and approval of batch records, SOPs, PV, CV, and APS documents; QMS management; trending and batch release activities; control and reconciliation of Master and Working Cell Banks

IPQA - Drug Product:

To execute IPQA Fill-Finish activities. including the review of SOPs, batch records, executed validations and media fills; line clearance for formulation and filling operations; and the management of change controls, deviations, OOS investigations, and trend analysis.

Saturday & Sunday, July 19 & 20, 2025

The Fern Kesarval Hotel & Spa Kesarval Gardens, Bus Stand, Edapally - Panvel Hwy, Cortalim, Quelossim, Verna, Goa 403710

PS: