Senior/ QA Executive (Pharmaceutical / Medical Device MNC)
Recruit Express Pte Ltd| Date Posted: 29-Aug-2019
EA Licence No: 99C4599|EA Personal Registration No: R1763413
Entry Level, Experienced
Bachelor's / Honours, Masters / PhD
- Quality oversight of Contract/External Manufacturers/3rd party logistics providers.
- Release of Products (Due diligence checks), evaluate product batch documentation ensuring that all batches have been released for supply in compliance with relevant regulatory and quality requirements and comply with relevant Marketing Authorisation details. To disposition goods i.e. to approve or reject, intermediate, bulk and finished products and ensure that supporting records are maintained.
- To write, review &/or authorise Quality documents and procedures as defined e.g. SOPs, WIs, forms, PQR, Deviation and Quality investigation reports.
- To maintain and manage Quality Management System (QMS) e.g. Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoring.
- To conduct internal audits as required.
- To support due diligence checks for new external contract manufacturers, new products and support external audits as required.
- To maintain and constantly improve the quality system.
- Min. requirement is a tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related science discipline.
- Min. 3 years’ experience in the pharmaceutical/ medical device industry with at least 2 years of QA experience in the pharmaceutical industry.
- Working knowledge of GMP in manufacturing environment.
- Working knowledge of GDP will be an advantage.
- Experience in supply chain quality, manufacturing quality or quality organisation in a commercial business will be an advantage
- Good working knowledge of deviation management, CAPA, change control and documentation management in a pharmaceutical / medical device industry.
- Be able to work independently and in a team environment with other staff.
- Auditing experience will be desirable.
For enquiries, you can contact Alex Goh Hock Leong - R1763413
**All information will be treated with the strictest confidence. We regret that only short-listed applicants will be notified.
Recruit Express Pte Ltd