Quality Systems Pharmacist

OLIC (Thailand) Limited

OLIC (Thailand) Limited (Bang Pa-in)

Ayutthaya, Thailand

OLIC has cultivated successful relationships that last. The company is a trusted partner to over 30 multinational companies, including most of the Big Pharma organizations. The OLIC manufacturing facility complies with GMP requirements following the PIC/S guide to Good Manufacturing Practice for Medicinal Products. Products made by OLIC serve not only the markets in Thailand and Southeast Asia, but also Japan, Australia, the US and Europe.

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Fungsi pekerjaan: Manajemen Kualitas

Industri: Manufaktur dan Produksi Kesehatan dan Medis

Detail posisi

The Quality Systems Pharmacist is responsible for ensuring compliance with GxP requirements through the planning and execution of cleaning validations, calibration management, and the development of QMS SOPs. This role involves collaboration with various teams to maintain quality standards and support audits.

Kewajiban

• Planning and execution of cleaning validations for manufacturing machines and equipment in order to comply with application GxP requirements.
• Planning and coordinating with area owners to ensure that analytical instrument and computerized systems are qualified prior to release to use compliant to the applicable QMS standard and GxP requirements.
• Planning and managing the calibration team to ensure that analytical instruments are calibrated in a timely manner and compliant to the applicable QMS standard and GxP requirement.
• Developing, reviewing and revising QMS SOPs/Wis to ensure the availability and up-to-date in all GxP concerned areas.
• Handling and following up system-related change in order to ensure completion of those actions in timely manner with compliance to GxP and customer requirements.
• Reviewing and taking parts in validation and qualification documentation such as URS, impact/risk assessment, master plans, qualification/validation documents.
• Participating in client, authority, and internal audits and coordinating with subdivisions in the organization in order to ensure effective auditing and compliance with applicable QMS and GxP requirements.
• Support the imports of medicinal and healthcare products.

Kualifikasi

• Bachelor’s degree in Pharmacist.
• At least 3 years in pharmaceutical manufacturing industry or related fields.
• Good analytical and problem solving skills.
• Strong interpersonal skills.
• Good command in English (MS Officer : Word, Excel, Power Point etc.)
• High ability to learn with good attitude.
• Enjoy Working with documentation and quality management systems.

Keuntungan

Huneety A.I Salary Estimate

20,000 - 35,000 THB per month