Technical Expert - QA Batch Release / Validation

2. Hi,

Rashmi.kulkarni1@Fresenius-kabi.com

Details as below :

1. Position : Senior Technical Expert- Quality Assurance

Key Responsibilities: - Validation Profile

• Validation Planning & Execution:

• Develop, review, and approve

  Validation Master Plans

  ,

  Validation Protocols

  (IQ/OQ/PQ), and

  Reports

  for equipment, utilities, and manufacturing processes.
• Lead validation activities for

  injectable dosage forms

  , including aseptic processing, lyophilization, and sterile filtration.
• Ensure validation activities comply with

  cGMP

  ,

  FDA

  ,

  EU

  , and other applicable regulatory standards

  1

  .

• Documentation & Compliance:

• Maintain and update

  Site Master File

  ,

  Annual Product Reviews

  , and

  Validation Summary Reports

  2

  .
• Review and approve

  SOPs

  ,

  Work Instructions

  , and

  Change Control

  documentation.
• Ensure traceability and archival of all validation documents.

• Cross-functional Collaboration:

• Coordinate with

  Production

  ,

  Engineering

  ,

  QC

  , and

  Regulatory Affairs

  to align validation efforts with project timelines.
• Support audits and inspections by providing validation documentation and responding to observations.

• Deviation & CAPA Management:

• Investigate validation-related deviations and implement

  Corrective and Preventive Actions (CAPA)

  .
• Conduct

  risk assessments

  and impact analyses for changes to validated systems

  3

  .

• Training & Support:

• Train operators and analysts on validation protocols and regulatory expectations.
• Provide technical support during equipment qualification and process validation.

2. Position : Technical Lead- Quality Assurance

Key Responsibilities: Batch Release

• Batch Documentation Review:

• Review

  Batch Manufacturing Records (BMR)

  and

  Batch Packaging Records (BPR)

  for completeness, accuracy, and compliance with

  cGMP

  .
• Ensure all documentation supports batch release and adheres to

  data integrity

  standards.

• Product Release Authorization:

• Authorize release of

  raw materials

  ,

  intermediates

  , and

  finished injectable products

  .
• Ensure specifications are met and documented evidence supports product quality.

• Deviation & CAPA Management:

• Escalate discrepancies and deviations promptly.
• Participate in investigations and ensure

  Corrective and Preventive Actions (CAPA)

  are implemented and closed.

• Compliance & Regulatory Support:

• Ensure batch release activities comply with

  FDA

  ,

  EU

  , and

  WHO GMP

  guidelines.
• Support internal and external audits by providing batch documentation and responding to queries.

• Cross-functional Collaboration:

• Coordinate with

  Production

  ,

  QC

  ,

  Regulatory Affairs

  , and

  Warehouse

  teams to ensure timely and compliant product disposition.
• Support continuous improvement initiatives in batch release processes.

• Documentation Control:

• Manage issuance, filing, and archival of executed batch records.
• Maintain batch documentation library and ensure traceability.