Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Senior Executive - Quality Assurance
Company:  Ahlcon Parenterals IN Ltd
Job Posting Location:  IN-Bhiwadi
Functional Area:  Quality
Working Model:  Onsite
Requisition ID:  2533

Ahlcon Parenterals (India) Limited, a B. Braun group company, located at Bhiwadi, Rajasthan is a major pharmaceutical formulation manufacturer of both Large and Small Volume Parenterals (LVP and SVP) for domestic as well as export markets. We commit to a Zero Defect Quality policy, made possible through the use of technologies and processess that ensure the delivery of high quality products and compliance to Current Good Manufacturing Practices. We also commit to sustainability efforts around our facilities and ensure compliance to global ISO standards.

Job Responsibility: 

  1. Responsible for executing and compilation all qualification/revalidation / requalification activities as per Schedule.
  2. Responsible for adherence of Protocols during validation activities.
  3. Responsible for execution and compilation of calibration activity of equipment & Instruments.
  4. Responsible for maintaining the calibration status / qualified status of equipment / system as per planner.
  5. Responsible for preparation and review of process validation, cleaning validation protocol and report.
  6. Responsible for execution of process validation, cleaning validation activity and compilation related documents as per schedule.
  7. Responsible for Preparation of HVAC Qualification Protocol & report, Execution & Compilation.
  8. Responsible for Execution & compilation of Aseptic Process Simulation Study.
  9. Responsible for Preparation of Qualification related document,
  10. Responsible for taking change control & Risk Assessment
  11. To Prepare the Process validation documents, activity Execution at shop floor, sampling as per design Protocol & compilation of activity.
  12. To Prepare the Cleaning validation documents, activity Execution at shop floor, sampling as per design Protocol & compilation of activity.
  13. Review of Process validation & Cleaning Validation documents as per current regulatory guidelines & update documents accordingly.
  14. To Prepare the Equipment qualification, Utility qualification, Visual checker qualification, CIP & SIP Validation documentation & Execution and compilation of the activity.
  15. To prepare & perform PLC & CSV qualification for Critical Equipment & Instruments.
  16. To Prepare the Equipment Qualification, HVAC & Sterilizer documents, activity Execution at shop floor, Sampling as per design Protocol & compilation of activity.
  17. Handling the Process Validation & Cleaning Validation document in audits.
  18. Handling the In Process Quality Assurance & Sampling Activity
  19. Good Regulatory audit Exposure (i.e. EU GMP, US FDA etc).
  20. Practical Skill in Ms Excel, Ms word, Ms Power point is required, skill in typing is preferred.
  21. Good Knowledge of regulatory (EU GMP / US FDA etc) requirements and exposure to regulatory audits required.

Qualification: B. Pharma/M. Pharma/M.Sc. 
Working Experience: 9 to 12 Year in Injection plant.

To know more about Ahlcon Parenterals you can visit our website https://www.ahlconindia.com/en.html
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