Deskripsi pekerjaan
The QA Inspector Staff is responsible for implementing Good Manufacturing Practice (GMP) guidelines, reviewing product batch records, and supporting quality-related business activities within a pharmaceutical manufacturing site. This role ensures that all manufacturing and packaging processes adhere to established SOPs and regulatory standards. Key duties include monitoring manufacturing processes, conducting GMP training for production personnel, and supporting investigations into deviations or quality events. The staff member also ensures the availability of necessary documentation for production and testing, while performing random sampling for specific deviation-related cases to maintain high-quality standards before product release.
Tanggung jawab: Ensure SOPs are implemented in compliance with GMP requirements across daily GMP activities.; Ensure the site is adequately prepared for internal and external audits.; Review finished product batch documentation, including manufacturing and packaging records and product inspection results, before product release.; Monitor manufacturing processes according to the established schedule.; Conduct GMP-related training for production personnel.; Support investigations of deviations/events related to GMP activities.; Ensure the availability of required documents for product manufacturing, packaging, and testing activities.; Perform random sampling for specific deviation-related cases..
Kualifikasi: Bachelor’s degree in pharmacy.; At least 1 year of experience as a QA Inspector in the pharmaceutical industry.; Proficient in chemical testing and instrumental analysis.; Good understanding of GMP.; Good command of the computer..
Tanggung jawab
- Ensure SOPs are implemented in compliance with GMP requirements across daily GMP activities.
- Ensure the site is adequately prepared for internal and external audits.
- Review finished product batch documentation, including manufacturing and packaging records and product inspection results, before product release.
- Monitor manufacturing processes according to the established schedule.
- Conduct GMP-related training for production personnel.
- Support investigations of deviations/events related to GMP activities.
- Ensure the availability of required documents for product manufacturing, packaging, and testing activities.
- Perform random sampling for specific deviation-related cases.
Kualifikasi
- Bachelor’s degree in pharmacy.
- At least 1 year of experience as a QA Inspector in the pharmaceutical industry.
- Proficient in chemical testing and instrumental analysis.
- Good understanding of GMP.
- Good command of the computer.
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi