Lowongan Kerja Serang Posisi Qa Executive di Flexicare (Group) Limited

Info Loker

Perusahaan	Flexicare (Group) Limited
Posisi	Qa Executive
Tempat	Serang
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	D3 (Diploma), D4 (Diploma)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Manufaktur, Penjaminan Kualitas / QA
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Description:

Quality Assurance Supervisor will establish quality regulations for products and employees. Should be able to analyse data in order to develop plans to motivate, and encourage employees while striving to improve processes and product quality.

He/ She should be able to plan and conduct validation activities, analyse data, and obtain relevant approvals. He/she should illustrate the required technical competencies in selecting proper  methods, acceptance criteria, statistical techniques, sample size relevant to Injection moulding, Extrusion processes, ETO sterilization and sterile barrier system based on Flexicare group guidelines and ISO 13485 requirements.

Work location: Cikande

Responsibilities:

• Product testing and defective product analysis;
• Analysis of process defects and root cause of complaints, follow-up of complaints / preventive corrective actions;
• Production of product inspection documents and related ISO forms;
• New product verification;
• New product testing and engineering improvement suggestions;
• Preparation of quality inspection standard documents (QAS, Control Plan);
• Handling and follow-up of customer complaints;
• QA personnel training;
• Operation monitoring of the quality management system;
• Compilation and improvement of quality management system documents;
• Auxiliary work for TUV Nord and CFDA audits;
• Complete other tasks assigned by the leader.
• Develop and Maintain validation plans and protocols that include methods, acceptance criteria, statistical techniques, sample size relevant to Injection molding and Extrusion processes
• Proceed relevant verification and validations and obtain approvals prior introduction of new equipment, test methods, molds, measuring and monitoring units to the manufacturing processes.
• Facilitate for the validation activities for sterilization and sterile barrier systems.
• Proper record keeping and prompt report generation.
• Technical support for plant trouble shooting activities along with maintenance department and ensure the conformity for the standard requirements.
• Document Control for ISO 13485
• Prepare SOP, WI, forms
• Coordinate and work closely with ISO consultant to achieve ISO 13485 certificate

Qualifications

• Engineering graduate from recognized University with Minimum 01-year experience in GMP environment.
• Familiar with CAD programs like AutoCAD and SolidWorks
• Experience in Validation in pharmaceutical / medical device industry will be added advantage.
• Confidence
• Excellent technical skills
• Good numerical skills and an understanding of statistics
• Leadership skills
• Planning and organization skills
• Communication and interpersonal skills
• Problem-solving skills
• Teamworking skills
• IT skills
• Ability to work independently
• Confidence
• Excellent technical skills
• Good numerical skills and an understanding of statistics
• Leadership skills
• Planning and organization skills
• Communication and interpersonal skills
• Problem-solving skills
• Teamworking skills
• IT skills

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Kesehatan/Medis
• No. Registrasi: 9109193
• Ukuran Perusahaan: 1001 - 2000 pekerja
• Waktu Proses Lamaran: 23 hari
• Tunjangan dan Lain-lain: Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja), will be advised during the interview
• Lokasi: Cikande