Officer Executive AM- Vaccine MfgR&DQuality

Hyderabad - India

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

About Cliet: Leading Vaccine and Biologics Manufacturing company with presence in Global Markets

Note: We have Multiple open positions in multiple departments as listed below.

Designation : AM /Executive/ Officer

Experience : 2 to 8 Years

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

Job Location : Hyderabad

MSAT – Upstream / Downstream / Analytical:

Knowledge of planning and executing the scale-up of fermentation processes strong mathematical skills specifically with respect to fermentation operation and scale-up.
Handling of FPLC systems like AKTA Avant AKTA pilot NGC and column packing etc experience in Techniques- cell lysis filtration TFF precipitation chromatography handling of inclusion bodies Disassembly reassembly.
Knowledge on Biochemical analytics like Bradford BCA Lowry anthorne orcinal PAGE
LAL endotoxin etc. Experience in handling operating and maintenance of HPLC UPLC GC MALS A4F systems.

Production – Bulk Manufacturing (Drug Substance / Antigens)

To perform documentation Inventory Sterilization of Materials Media Preparation and Filtration supporting during upstream and downstream activities.
To perform cell culture and virus culture activities.
Preparation and maintenance of cell banks (Master and Working seed banks)
QMS related activities like Change Controls Deviations Commitment Tracker using Track wise.
Deep understanding of process knowledge and trending of process data using statistics-based tools.
To perform the manufacturing Tech support & own process related investigations & CAPA’s of Manufacturing.

Production Formulations (Injectables / Secondary Manufacturing)

Blending:

Ability to manage shift plans for formulation activities. Operate and maintain equipment such as autoclaves and blending vessels CIP and SIP skids

Filling:

Operation and cleaning of Vial washing machine and Vial Sterilization tunnel in Filling area. Responsible for Cleaning and disinfection of the Filling areas and Cleaning of components and preparation of loads
Ensuring line clearance activities at each stage of process in Grade D C and B areas and Monitoring the Operation of Filling vessels.

Quality control (Biologics / Vaccines):

Biochemical Assays & Immunochemical:

Involved in the estimation of total and free components in polysaccharides along with biochemical analyses such as protein nucleic acid aluminium content and composition analysis. Experience in analytical method validation adherence to ALCOA principles and management of OOS and OOT investigations. Molecular techniques such as SDS: PAGE Western Blot Slot blot PCR and ELISA is preferred.

Virology:

Experience in in-vitro viral testing of starting materials raw materials in-process final bulk final lot and stability samples for viral vaccines. Review testing for the QC release of products RM stability studies of viral vaccines and new projects/products.

Quality Assurance

IPQA - Drug Substance:

Ensure that Bulk Viral Antigen production adheres to GMP on the shop floor line clearance dispensing and preparation processes are executed as part of IPQA activities. Reviewing and approving batch records SOPs PV CV and APS documents; managing QMS; trending and batch release activities; controlling and reconciling Master and Working Cell Banks.

Required Skills:

Upstream Downstream Vaccine purification

About Cliet: Leading Vaccine and Biologics Manufacturing company with presence in Global MarketsNote: We have Multiple open positions in multiple departments as listed below.Designation : AM /Executive/ OfficerExperience : 2 to 8 YearsQualification : ...