QC Qualification Engineer
2 months ago
ResponsibilitiesSupport Change Controls initiation and end-to-end ownership for Temperature Chambers (Fridges/ Freezers/ Incubators).Responsible for D.....
Responsibilities
- Support Change Controls initiation and end-to-end ownership for Temperature Chambers (Fridges/ Freezers/ Incubators).
- Responsible for Drafting and executing Validation related documents (Validation Plan & Requirement, IOQ/PQ Test Scripts, Summary report, Data Integrity Risk Assessments).
- Responsible for Drafting Operations and Maintenance SOPs.
- Support in generation of Preventive Maintenance program for Temperature Chambers.
- Coordination with equipment vendor for vendor qualification activities Coordination with different stakeholders’ functions (F&E, QA, QC, Automation, IT).
- Coordination for Calibration of Temperature Chambers (Fridges/ Freezers/ Incubators).
Requirements
- Related working experience in biotech or pharmaceutical operation environment is preferred.
- Strong understanding of various validation approaches, strategies and philosophies.
- Working knowledge of lab instruments and computerized system validation, controlled temperature chambers qualification etc.
- Working experience with KNEAT / electronic validation tools are preferred.
- Experience with change control methodology.
- Good knowledge in data integrity, GMP and GDP.
- Ability to facilitate and work in a
- collaborative team-based environment.
- Team player with strong focus on safety, quality and timeline.
- Able to work independently with minimal supervision.
Official account of Jobstore.