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Walk-in Drive in Quality Assurance, Bio-Bulk Manufacturing at Enzene Bioscience’s- 25th Aug 2024

Enzene Biosciences
Pharmacareer

Website Enzene Biosciences

About Enzene Biosciences
Enzene Biosciences is a technology-driven company based in Pune, India, committed to harnessing disruptive innovation to enhance global health. Our mission is to provide affordable, high-quality medicine to improve the lives of individuals with debilitating conditions. With a world-class R&D infrastructure, we offer access to advanced technologies and an end-to-end development platform, ranging from proprietary CHO duos cell lines to comprehensive drug product development. Our cutting-edge analytical technologies accelerate the development of pre-clinical and clinical drug candidates.

Position: Quality Assurance (QA) Professionals
Location: Hyderabad
Experience Required: 4 to 12 Years
Qualification: M.Sc/M.Tech/M.Pharm (Biotech, Bioprocess Technology, Life Sciences)

Job Responsibilities:

Vendor Management

  • Oversee vendor management, including the qualification and management of contract vendors and external service providers.
  • Ensure compliance with quality management systems (QMS).

Validation QA

  • Review validation protocols and reports, such as URS, DQ, IQ, OQ, and PQ, particularly for cold chain products.
  • Manage equipment validation and qualification for pharmaceutical sterile facilities.

Training & Development

  • Design, implement, and oversee training programs to enhance employee skills and ensure compliance with industry standards.
  • Collaborate with departments to identify training needs, develop materials, and evaluate program effectiveness.

Bio-Bulk Manufacturing (Drug Substance)

  • Upstream Process: Expertise in media preparation, filtration, aseptic techniques, and handling of bioreactors.
  • Downstream Process: Proficiency in buffer preparation, filtration techniques, and chromatography.

Upstream Process Development (UPD)

  • Mammalian: Handling AMBR250, expertise in perfusion technology, and process optimization.
  • Microbial: Experience with fermenters, process optimization, and characterization.

Advance Analytical Technique (AAT)

  • Proficient in analytical method development, qualification, and transfer.
  • Experience with HPLC, UPLC, and other analytical instruments.

Method Validation Lab (Quality)

  • Perform method validation, stability sample analysis, and data review.
  • Coordinate external calibration and in-house verification of instruments.

Downstream Process Development (DSP/PPD)

  • Develop protein purification processes and troubleshoot manufacturing issues.
  • Draft and review study protocols and reports.

Drug Product Development (DPD)

  • Experience in formulation development for therapeutic proteins.
  • Knowledge of combination product development and regulatory requirements.

Quality Management System (QMS) – Quality Assurance (QA)

  • Conduct investigations, manage deviations, CAPA, and change control.
  • Ensure compliance with regulatory guidelines like USFDA and EMA.

In Process Quality Assurance (IPQA)

  • Oversee batch manufacturing and perform online review of BMR.
  • Coordinate with clients for report reviews and batch release.

Analytical Quality Assurance (AQA)

  • Manage stability protocols, data review, and chamber maintenance.
  • Review analytical and microbial data for compliance.

Quality Control Analyst and Reviewer (QC Analytical)

  • Perform and review analytical tasks such as HPLC and ELISA.
  • Prepare and review documents related to GMP, GLP, and regulatory standards.

Domestic Regulatory Affairs (Domestic-RA)

  • Provide regulatory input and documentation for biological products in India and ROW markets.
  • Review documents and maintain regulatory product processes.

Global Regulatory Affairs (Global-RA)

  • Draft and review eCTD sections for regulated markets like the USA, Europe, and Canada.
  • Devise strategies for eCTD filing and manage developmental requirements.

Walk-in Interview Details:
Date: Sunday, 25th August 2024
Time: 9:30 AM – 6:00 PM
Venue: Hotel Green Park, Greenland, Begumpet, Hyderabad – 16

Join us in our mission to innovate and improve global health. We look forward to meeting talented professionals eager to make a difference in the pharmaceutical industry!

To apply for this job please visit docs.google.com.