Compliance (Equipment Qualification & Validation)

Job Description:

• Handling of Commissioning and Qualification in eVLMS.
• Commisioning and Qualification of System using the tools and features available in eVLMS application.
• Protocol execution and control of Comissioning and Qualification documents in eVLMS across Biocon Biologics.
• Identification and raising deviation, change control and compiling other eGMP related document in coordination with QA.
• Lead for study execution and requalification activities for autoclave, formulation vessels, combi filling machines and tunnels.
• Responsible in handling qualification documentation in trackwise such as change controls, change actions and CAPA.
• Coordinate and execute Equipment Qualification activities annually or as needed.
• Maintain documentation for Validation activities, including Equipment Qualifications, Process Performance
• Qualification, and Cleaning Validation.
• Follow GMP practices and internal procedures, reporting issues to superiors promptly.
• Execute qualification activities, including pre-requisites, during and after completion.
• Maintain pre-requisites for qualification and validation.
• Record equipment qualification details accurately in the system.

• Coordinate in QMS activity to ensure closure on time
• Organize and monitor team members do the production activities for timely production of high quality products, in a cost effective manner, under safe conditions and according to cGMP requirements.
• To strictly adhere to the Standard Operating Procedure and Good Documentation Practices.
• Ensure production personnel strictly adhere to Standard Operating Procedure and Good Documentation Practices.
• Ensure online documentation practiced in production.
• Able to represent department during external audit.
• Knowledge in cGMP.
• Familiar with Pharmaceutical guideline.

Job Description:

• Handling of Commissioning and Qualification in eVLMS.
• Commisioning and Qualification of System using the tools and features available in eVLMS application.
• Protocol execution and control of Comissioning and Qualification documents in eVLMS across Biocon Biologics.
• Identification and raising deviation, change control and compiling other eGMP related document in coordination with QA.
• Lead for study execution and requalification activities for autoclave, formulation vessels, combi filling machines and tunnels.
• Responsible in handling qualification documentation in trackwise such as change controls, change actions and CAPA.
• Coordinate and execute Equipment Qualification activities annually or as needed.
• Maintain documentation for Validation activities, including Equipment Qualifications, Process Performance
• Qualification, and Cleaning Validation.
• Follow GMP practices and internal procedures, reporting issues to superiors promptly.
• Execute qualification activities, including pre-requisites, during and after completion.
• Maintain pre-requisites for qualification and validation.
• Record equipment qualification details accurately in the system.

• Coordinate in QMS activity to ensure closure on time
• Organize and monitor team members do the production activities for timely production of high quality products, in a cost effective manner, under safe conditions and according to cGMP requirements.
• To strictly adhere to the Standard Operating Procedure and Good Documentation Practices.
• Ensure production personnel strictly adhere to Standard Operating Procedure and Good Documentation Practices.
• Ensure online documentation practiced in production.
• Able to represent department during external audit.
• Knowledge in cGMP.
• Familiar with Pharmaceutical guideline.