Lowongan Kerja Batang Posisi Sterilization And Verification Assistant Manager di PT Ace Medical Products Indonesia

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Perusahaan	PT Ace Medical Products Indonesia
Posisi	Sterilization And Verification Assistant Manager
Tempat	Batang
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Manajemen (Kesehatan & Medis)
Gaji Min	Rp. 2.000.000
Gaji Max	Rp. 8.500.000

Requirement :

1.      Bachelor’s degree or above, preferably in Pharmaceutical Engineering, Chemical Engineering, or related fields.

2.      Fluent in English (spoken and written), Chinese is preferred.

3.      Strong learning ability and curiosity, with the capability to quickly acquire new knowledge and skills.

4.      Excellent problem analysis and problem-solving skills.

5.      Strong communication skills and a collaborative

Job Descriptions :

1.      Perform validation to ensure that each stage of the production process of medical devices meets the established standards and regulations.

2.      Supervise compliance of special processes (such as sterile packaging, sterilization, and other special procedures).

3.      Responsible for the validation of special process technologies and equipment (including sterilization and sterile packaging processes), periodic evaluations, and revalidation.

4.      Assess changes related to special processes and evaluate anomalies in special processes.

5.      Develop product validation plans, including functional testing, durability testing, and safety testing to ensure the product meets technical specifications.

6.      Adhere to the company’s quality management system and relevant regulatory requirements to ensure compliance in validation work. Participate in internal audits and management reviews, promptly identifying and addressing issues in the validation process.

7.      Ensure all validation activities comply with regulatory bodies such as FDA, CE, ISO 13485, and other industry standards.

8.      Create and maintain validation documentation, including test reports, protocols, and validation certificates required for audits and regulatory purposes.

1. Analyze validation results and provide management with reports on compliance status, test outcomes, and any corrective actions required.

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