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API – Production | Biocon Ltd | Bengaluru

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Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Head Aseptic Manufacturing Operations

Location: Bengaluru, Karnataka, India

Job Description:

Roles and Responsibilities

    • Carry out shift operations ( Unit operation like Operating Reactors, centrifuges, clean room equipment etc, Hydrogenation, handling Nbl reaction, etc)
    • Adherence to Safety, Health, and Environment measures.
    • Reporting of non-conformities and adherence to the corrective/preventive actions in specific areas of operation.
    • Authorized to raise Deviation Reports and Change Controls.
    • Co-ordination with QA for line clearance during product change over.
    • Authorized to prepare, issue and review quality documents (authorized person from next senior level).
    • Maintenance of production-related documents and quality records.
    • Initiation of corrective and preventive actions against non-conformance.
    • Overall coordination with other departments related to production activities.
    • Adherence to Quality Policy and Quality Management System.
    • To coordinate with QA for all the validation, qualification and Audit preparedness
    • Calibration of weighing instruments in production.
    • Adherence to and creating awareness about Standard Operating Procedures and product specifications.
    • Finished product quarantine/inspection/packaging/storage.
    • To monitor housekeeping
    • To perform equipment cleaning.
    • In-process product sampling, inspection, and storage.
    • Data entry in Quality records.
    • Adherence to Good manufacturing practices.
    • Adherence to cGMP.
    • Reporting of product/system non-conformities, and implementation of corrective/ preventive actions in specific areas of operation.
    • Preparation of SOP’s, ECC’s, EOP’s, Checklists and Log sheets (Authorized person by Department Head.)

Technical/Functional Skills:

  • Good knowledge of centrifuge, reactors, filter pumps, techniques & aseptic operations.
  • Should have experience in Current Good manufacturing practices. (cGMP)
  • Good documentation skills
  • Awareness of audit requirements.
  • Knowledge of documentation for USFDA & EU ,ability to troubleshoot problems.

Qualification: B. Sc – Chemistry/Diploma – Chemical Engineering

Experience: 1-6 years of Relevant Experience

Salary: Negotiable

Contact Details:]

Pulla Rao

pullaroa.yarramsetti@biocon.com

human.resources@biocon.com, careers@biocon.com, 

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