1 день назад
GBS H&N Pharma Quality Assurance Associate (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GBS H&N Pharma Quality Assurance Associate (Pharma Quality Assurance): Managing pharmaceutical quality assurance activities, including change controls, document control, training records, quality agreements, vendor evaluations, and audit responses with an accent on GMP compliance, regulatory documentation, and cross-functional coordination. Focus on maintaining test methods and specifications, releasing Certificates of Analysis, coordinating corrective actions, and ensuring timely closure of quality processes.
Location: Filinvest Ave, Muntinlupa, Metro Manila, Philippines
Company
provides inspection, verification, testing, and certification services through a global network of offices and laboratories.
What you will do
- Review and approve Change Control Requests and coordinate their timely closure with process owners.
- Manage site training and document control systems, including document setup, approvals, periodic reviews, and training records.
- Maintain client test methods and specification databases and coordinate Quality Agreement approvals with internal, client, and legal stakeholders.
- Coordinate internal, client, and regulatory audits and prepare responses to audit findings.
- Provide backup QA support, including Certificate of Analysis release, vendor evaluations, method and specification assessments, and corrective-action follow-up.
- Support operational improvement initiatives and complete assigned quality projects in accordance with procedures and integrity standards.
Requirements
- Bachelor’s degree in a scientific field.
- At least 3 years of Quality Assurance experience in the pharmaceutical industry.
- Understanding of relevant GMP regulations; knowledge of USP compendiums is preferred.
- Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, with the ability to learn new technologies quickly.
- Excellent written and strong verbal English communication skills at C1 level.
- Experience writing protocols and reports in accordance with regulatory standards, with strong organization, prioritization, and attention to detail.
Nice to have
- Knowledge of USP compendiums.
Culture & Benefits
- Full-time employment.
- Work aligned with quality, health, safety, environment, and integrity standards.
- Opportunities to participate in operational improvement activities and professional training or development.
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