Quality Assurance Specialist
The Client
International - well known Pharmaceutical company.
The Role
- Develops an understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas.
- Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
- Reviews and approves system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas
- Consults with CSQM team members and relevant internal stakeholders to identify/define high-risk areas with the intent on focusing on patient safety, product quality, and data integrity.
- Participates in performing Periodic Review activities of Computerized Systems
- Provide support to regulatory inspection preparedness activities as needed
- Experience performing Infrastructure Qualification activities
The Person
- Bachelor's Degree in Pharmacy or Science or any other related field
- Minimum 3 years Quality Assurance experience in the pharmaceutical or healthcare industry
- A few years of experiences in pharmacovigilance activities
- Good understanding of GMP regulations, guidelines and policies governing the healthcare industry (pharmaceutical, cosmetic, medical device)
- Great communication skills - about to coordinate with both internal cross-department and with clients
APPLICANTS WHO DO NOT MEET THE ABOVE CRITERIA WILL NOT BE CONSIDERED.
If you have any queries, please call Khun Thanyaporn on +66 (0) 2 107 2571 or tlongprasert@argyllscott.co.th
Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.
