2 дня назад
Pharma Document Reviewer (Pharmaceutical Laboratory Experience is required)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Pharma Document Reviewer (Pharmaceutical Laboratory Experience is required) (Pharmaceutical Quality): Reviewing pharmaceutical QC records and laboratory documentation for compliance with methods, specifications, SOPs, and cGMP requirements with an accent on LIMS data verification, validation records, and analytical result reporting. Focus on identifying deviations and OOS issues, auditing quality records, and improving document review processes.
Location: Muntinlupa City, Metro Manila, Philippines; hybrid arrangement with onsite work required for 2 to 6 months
Company
SGS is a global testing, inspection, and certification company focused on quality, integrity, and safer interconnected operations.
What you will do
- Review QC records for compliance with analytical methods, specifications, and applicable SOPs.
- Verify that laboratory results are completely documented and entered into LIMS.
- Review validation, method transfer, method verification, method development, and related reports.
- Ensure results are appropriately reported on Certificates of Analysis or Reports of Analysis.
- Audit logbooks, calibration records, and other quality-control documentation.
- Manage deviations and OOS issues, document deficiencies, escalate concerns, and support process improvements.
Requirements
- Bachelor of Science degree in Chemistry or Microbiology; a Master of Science is preferred.
- At least 5 years of experience in a pharmaceutical laboratory or pharmaceutical company.
- Understanding of cGMP regulations and required knowledge of compendiums such as USP; EP is preferred, while JP and BP are advantageous.
- Experience with LIMS and multiple instrument management systems, such as Empower.
- Proficiency in Microsoft Word, Excel, and Outlook.
- Strong written and verbal English communication skills at B2+ level; willingness to work onsite for 2 to 6 months.
Nice to have
- Experience with TrackWise Digital or another QMS system.
- Master of Science degree.
- Knowledge of EP, JP, or BP compendiums.
Culture & Benefits
- Work in a global network of testing, inspection, and certification offices and laboratories.
- Follow SGS quality assurance, QHSE, HR, integrity, and professional conduct standards.
- Maintain training records and participate in training on SOPs, tests, instruments, and procedures.
- Coordinate multiple projects in a fast-paced professional environment while prioritizing deadlines.
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