Validation Executive-QA/Corporate Quality

2 days ago

Baddi, Himachal Pradesh, India Venus Remedies (VRL) Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

The Executive QA Validation will be responsible for executing and ensuring compliance of validation activities in the Injectable (Sterile) manufacturing facility, including equipment, utilities, cleaning, process, computerized systems, and analytical methods. The role requires adherence to cGMP, regulatory guidelines, and internal SOPs to ensure that all validation practices support product quality and regulatory requirements.

Key Responsibilities:

  • Execution and review of validation activities for sterile injectable dosage forms, including:

  • Equipment Qualification (IQ/OQ/PQ)

  • Utility Qualification (HVAC, Water Systems, Compressed Air, Clean Room Validation)
  • Process & Cleaning Validation
  • Analytical Method Validation

  • Computer System Validation (CSV)

  • Preparation, review, and execution of Validation Protocols, Reports, and related documentation in compliance with cGMP.

  • Execution and monitoring of aseptic media fill (process simulation) studies.
  • Calibration and qualification support for critical instruments used in sterile manufacturing.
  • Risk assessment and gap analysis related to validation activities.
  • Coordination with cross-functional teams (Production, QC, Engineering, Regulatory) for timely execution of validation projects.
  • Ensure compliance with current regulatory requirements (USFDA, EU GMP, MHRA, WHO, etc.).
  • Participation in internal and external audits/inspections and preparation of necessary validation documents.
  • Review and update of SOPs related to validation activities.
  • Support in continuous improvement initiatives related to process and equipment validation.

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