
Quality Assurance Professional
2 weeks ago
We are seeking a proactive and detail-oriented quality assurance expert to support key quality initiatives within the quality monitoring team.
Key Responsibilities:
- Collaborate with inter-departmental and cross-functional teams to drive quality excellence.
- Author high-quality site contributions to annual product quality reviews and coordinate with global teams.
- Conduct counterfeit assessments related to product complaints.
- Investigate customer complaints in a timely and thorough manner.
- Collect and report on quality metrics to inform business decisions.
- Contribute to the authoring, reviewing, and approval of standard operating procedures (SOPs) and other controlled documents.
- Conduct quality assurance walkthroughs to ensure site compliance with good manufacturing practice (GMP) requirements.
Qualifications and Experience:
- Minimum of 2 years of relevant experience in a GMP-regulated environment.
- Bachelor's degree in a scientific or related field.
- Previous experience in the pharmaceutical industry, ideally within a quality assurance function, is preferred.
- Strong working knowledge of current good manufacturing practices (cGMPs) and quality systems (FDA/EMA standards).
- Familiarity with OPEX lean tools and root cause analysis methodologies.
- Demonstrated skill in audits, investigations, and technical report writing.
- Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
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