Deskripsi pekerjaan
Standard Biosensor Healthcare is a company dedicated to the healthcare sector, focusing on the production and quality management of medical devices. This full-time role is based in Purwakarta, Jawa Barat, and is central to maintaining the safety and efficacy of the company's pharmaceutical and medical product lines. As a Quality Assurance Staff, you will be responsible for the end-to-end validation process. This includes establishing validation strategies based on risk assessments, preparing and reviewing Process Validation Protocols, and ensuring all activities align with approved protocols. You will also conduct IQ/OQ/PQ activities, collect and evaluate data, prepare comprehensive validation reports, and assess the necessity for revalidation whenever there are changes to processes, equipment, materials, or facilities.
Tanggung jawab: Prepare validation and qualification schedules based on priority and risk assessment.; Establish validation strategies based on risk assessment.; Ensure all validation activities are conducted in accordance with approved protocols.; Prepare and/or review Process Validation Protocols.; Conduct IQ/OQ/PQ activities as required.; Collect and evaluate validation data.; Prepare Validation Reports upon completion of validation activities.; Assess the need for revalidation when there are changes to processes, equipment, materials, facilities, or critical parameters..
Tanggung jawab
- Prepare validation and qualification schedules based on priority and risk assessment.
- Establish validation strategies based on risk assessment.
- Ensure all validation activities are conducted in accordance with approved protocols.
- Prepare and/or review Process Validation Protocols.
- Conduct IQ/OQ/PQ activities as required.
- Collect and evaluate validation data.
- Prepare Validation Reports upon completion of validation activities.
- Assess the need for revalidation when there are changes to processes, equipment, materials, facilities, or critical parameters.
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Negosiasi