Senior Technology Auditor, QA
New
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 4 years of experience in quality assurance and auditing; at least 7 years of experience in clinical research, regulatory affairs, or related life sciences fields.
- Required Skills
- Microsoft OfficeQuality Assurance
Requirements
- Bachelor’s degree in technology, biological sciences, pharmacy, healthcare, or a related discipline, or equivalent professional experience.
- Minimum of 4 years of experience in quality assurance and auditing, including significant experience with GxP audits.
- At least 7 years of experience in clinical research, regulatory affairs, monitoring, data management, pharmacovigilance, laboratory operations, supplier management, or related life sciences fields.
- Strong knowledge and practical understanding of GxP standards, clinical trial regulations, and international quality requirements.
- Experience leading complex audits, preparing audit reports, managing findings, and supporting corrective action processes.
- Excellent analytical, problem-solving, organizational, and decision-making skills with strong attention to detail.
- Ability to manage multiple projects, prioritize workloads, and work effectively in a fast-paced global environment.
- Strong interpersonal and communication skills, including the ability to present findings, conduct training, and influence stakeholders.
- Experience working within multicultural and matrix organizations with multiple stakeholders.
- Proficiency with Microsoft Office tools.
- Willingness to travel internationally as required, with travel potentially reaching approximately 60%.
Responsibilities
- Lead, plan, conduct, and report GxP audits across clinical research activities, including project audits, system and process audits, supplier audits, trial documentation reviews, and safety-related audits.
- Deliver high-quality audit reports within agreed timelines, identify improvement opportunities, and provide clear recommendations to strengthen quality processes.
- Manage audit findings by reviewing responses, monitoring corrective and preventive actions (CAPAs), and escalating risks when required.
- Coordinate internal and global audit programs by developing audit tools, tracking deliverables, analyzing trends, and reporting outcomes to quality leadership.
- Act as a quality advisor to internal teams and clients, providing guidance on regulatory expectations, compliance requirements, and effective quality practices.
- Support client audits and regulatory inspections by coordinating preparation activities and ensuring successful engagement with external stakeholders.
- Provide mentoring, training, and knowledge sharing to auditors and team members to strengthen audit capabilities.
- Maintain accurate quality records, audit documentation, and reporting systems while contributing to process optimization initiatives.
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