QA-Technical Pharmacist - OLIC ( THAILAND ) Limited

• Responsible to review product specification and test method against the updated version of compendial pharmacopoeia and the registration file to ensure that the regulatory compliance are maintained.
• Initiate change control related to change in product specification and test method and co-ordiante with Quality team to support submission amendment, follow up, until implementation the new specification and test method.
• Coordinate with quality, production, product development and regulatory team to support stability study of the new project.
• Primary review stability program for on-going stability study and special stability regarding to the change controls and stability of the new product / project.
• Follow up the stability data and also provide report / document to client in order to support new project requirement.
• Provide the registration dossier in part of stability for submission to health authority and also response to client and health authonty for any query related to submission dossier.
• Support preparation of the Annual Product Quality Review (APR/PQR) within the established schedule in accordance with company and regulation requirements.
• Extraction and data compilation of analytical, manufacturng, quality control and regulatory data.
• Collect finished product and stability data for evaluation the product quality results and identify the product quality trend.

• Bachelor’s Degree in Pharmaceutical Science.
• Experience in Pharmaceutical industry will be advantage.
• Good command in English and computer literacy.
• Strong interpersonal and communication skill, Hard working, Pro-active, Analytical skill and problem solving skill.
• Good technical writing skills, file organization and the ability to manage data is required.
• Strong understanding of relevant regulatory guidelines and requirements.
• High responsible with the timeline commitment.
• Patient, positive thinking and good attitude.
• Ability to manage multiple tasks.

Toll and contract manufacturer of choice for Global Pharmaceutical, Healthcare and Personal Care companies.

OLIC has cultivated successful partnerships that last.

The company is a trusted partner of more than 30 multinational companies, including most of the Big Pharma organizations. The OLIC Manufacturing facility complies to GMP requirements to the PIC/S guide for Good Manufacturing Practice for Medicinal products. Products made by OLIC are serving not only markets in Thailand and South-East Asia, but also Japan, Australia, US, and Europe.