QA-Technical Pharmacist - บริษัท โอลิค (ประเทศไทย) จำกัด

Responsibilities

Responsible for the preparation of the Annual Product Quality Review (APR/PQR) within the established schedule in accordance with company and regulation requirements. Also provide the registration dossier for submission to health authority for local and domestics.
Extraction and data compilation of analytical, manufacturing, quality control and regulatory data.
Collect finished product and stability data for evaluation the product quality results and identify the product quality trend.
Writing and updating applicable SOP to comply with GMP standard and international guideline.
Preparing the registration dossier in CTD, ACTD as well as country specific format for countries.
Co-ordinate with quality, production, product development and regulatory team for the availability of data to meet the requirement from health authority.
Response to client and health authority for any query related to submission dossier.

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.

QA-Technical Pharmacist

ปริญญาตรี

สามารถเจรจาต่อรองได้

วันนี้

รายละเอียดงาน

หน้าที่และความรับผิดชอบ

Responsible for the preparation of the Annual Product Quality Review (APR/PQR) within the established schedule in accordance with company and regulation requirements. Also provide the registration dossier for submission to health authority for local and domestics.
Extraction and data compilation of analytical, manufacturing, quality control and regulatory data.
Collect finished product and stability data for evaluation the product quality results and identify the product quality trend.
Writing and updating applicable SOP to comply with GMP standard and international guideline.
Preparing the registration dossier in CTD, ACTD as well as country specific format for countries.
Co-ordinate with quality, production, product development and regulatory team for the availability of data to meet the requirement from health authority.
Response to client and health authority for any query related to submission dossier.

คุณสมบัติ

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.

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