Lowongan Kerja Pasuruan Posisi Quality Assurance Associate di Seasonal Visions International Ltd

Info Loker

Perusahaan	Seasonal Visions International Ltd
Posisi	Quality Assurance Associate
Tempat	Pasuruan
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	Diploma Pascasarjana, Gelar Professional, Magister (S2), Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Manufaktur, Penjaminan Kualitas / QA
Gaji Min	Rp. 22.500.000
Gaji Max	Rp. 25.000.000

Quality Assurance Associate

We are actively searching for a dynamic candidate who can step into a key role, providing essential support to SVI’s business partners and contract manufacturing associates. This position provides a unique opportunity for the selected candidate to gain invaluable insights into this operational setup

Overview:

The Quality Assurance Associate will work to ensure that the quality standards of the company are maintained within procedures, policies, purchased components and manufactured products.Quality Assurance Associate will be on site at our contract manufacturer to help oversee and support the compliant implementation of processes and procedures including the eQMS as well as support other functions of the Quality Department as needed. 

Primary Responsibilities:

Working onsite at Pasuruan, East Java to support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, relevant regulatory requirements, and industry guidance. Specific areas of responsibility include, but are not limited to: 

• Document control, creation of quality documents, and review/approval of controlled documents 
• Change management and review of change controls 
• Training program; conduct training when needed 
• Execution and continual improvement of QMS program 
• Member of the internal auditing team, participate in conducting internal audits 
• Assist Quality Control & production departments in the evaluation of quality issues (including customer & supplier issues) using statistical & problem-solving techniques to determine root cause, implement corrective & preventive actions and improve processes 
• Assist in resolution of quality issues by communicating effectively with internal and external customers 
• Support the upkeep of the Quality Document Management System, including but not limited to: Batch Records (master records and executed records), Change Controls, Deviations/Investigations, Audit Reports, Corrective Action Requests, Standard Operating Procedures, Annual Product Reviews, and Customer Complaints. 
• Participate in Quality and Compliance Vendor Management activities including audits and site-visits as needed. 
• Liaise closely with contract manufacturing partner to ensure compliance with corporate, regulatory and industry standards. 

Minimum Qualifications: 

• Strong computer skills, i.e. Excel/Word/PowerPoint/Visio/eQMS  
• Requires a bachelor’s degree preferably in a life science, engineering or business-related field plus a desired 2-5 years of relevant experience. Experience includes Quality Assurance/Control in a pharmaceutical or other regulated environment.   
• Requires the ability to read, write, and communicate fluently in English.  
• Must be able to work independently and with self-confidence, and be self-motivated.

Preferred Qualifications:  

• Strong knowledge of cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems.  
• Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment. 
• Experience with international regulatory requirements and international business partners is preferred. 
• Experience managing complex projects with remote team members 
• Experience with statistical software programs 
• Ability to work with a wide range of people for process improvements and corrective actions 
• Ability to work independently and within team environments.    
• Ability to conduct internal audits with minimal supervision 
• Experience with QMS software applications 

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Umum & Grosir
• No. Registrasi: -
• Ukuran Perusahaan: 201 - 500 pekerja
• Waktu Proses Lamaran: 19 hari
• Lokasi: Pasaruan city