Executive/Sr.Executive
Qualification& Validation Expert
Job Title:
Executive/Sr.Executive Qualification& Validation Expert
Location:
Medchal ,Hyderabad, India
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
- Performing risk/gap assessments
- 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
- Conducting effective risk /gap assessments
- Technical writing skills
- Familiar with standards/ regulatory guidance documents
Desired:
- Preferably from Human Vaccines or Pharma Injectables background
- Good Communication skills.
- Proficient in MS Office