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1 день назад

GBS H&N Pharma Quality Assurance Associate (Pharma)

Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Philippines
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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 hirify.global 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 hirify.global quality, health, safety, environment, and integrity standards.
  • Opportunities to participate in operational improvement activities and professional training or development.

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