Executive / Sr.Executive - Qualification & Validation Expert

Shantha Biologics Pvt. Ltd.; Hinoba-an; On-site; PHP 800,000 - 1,200,000; Full time

Job summary

Shantha Biologics Private Limited in the Philippines seeks an Executive/Sr. Executive Qualification & Validation Expert to lead qualification and validation activities across facilities and equipment.

Responsibilities include preparing validation SOPs, IQ/OQ/PQ protocols, and executing qualification tasks for HVAC, water systems, gases, sterilizers and temperature-controlled units. The ideal candidate has 4–6 years in vaccines or pharmaceutical validations, strong technical writing, and

Qualifications

• Experience in vaccines/pharmaceutical validations.
• Strong technical writing abilities.
• Familiarity with regulatory guidance documents.
• Background in Human Vaccines or Pharma Injectables preferred.

Responsibilities

• Prepare validation SOPs.
• Prepare IQ/OQ/PQ protocols.
• Execute qualification/validation activities for HVAC, water systems, gases, sterilizers, and temperature-controlled units.
• Perform routine requalification/re-validation.
• Compile data and prepare reports.
• Inventory management of validation consumables.
• Manage validation equipment.
• Support audit readiness and engineering activities.
• Contribute to QMS actions (Deviations, Change Controls & CAPA).
• Support reporting manager in other activities as assigned.

Skills

Execution of qualification/validation

Technical writing

Regulatory guidance familiarity

Vaccine/pharma background preferred

Job description

Executive/Sr.Executive
Qualification& Validation Expert

Job Title:

Executive/Sr.Executive Qualification& Validation Expert

Experience:

4-6 years in vaccines/pharmaceutical validations

Job responsibilities:

• Preparation of validation SOPs
• Preparation of Qualification & Validation protocols (IQ, OQ&PQ)
• Execution of Qualification & Validation activities for Facilities, Utilities &Equipment
  • HVAC System
  • Water systems (PW, WFI, Pure Steam)
  • Gases (Compressed air, Nitrogen etc)
  • Moist Heat Sterilizers
  • Dry Heat/Tunnels
  • Temperature controlled units (Cold rooms, freezers, incubators etc.)
  • Steam quality testing
• Performing Routine requalification/re-validation
• Execution data compilation and report preparations
• Inventory maintenance and control for validation consumables.
• Management of validation equipment
• To support in audit readiness
• To support engineering activities part of engineering assurance
• Involve and support in functional related QMS actions (Deviations, Change Controls & CAPA)
• Support reporting manager in other activities as assigned.

Required skills:

• Expertise in execution of qualifications/validations
• Technical writing skills
• Familiar with standards/ regulatory guidance documents
• Preferably from Human Vaccines or Pharma Injectables background