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SalaryUnder the supervision of Manager, Quality Assurance, the Associate, Quality Assurance (QA) will assist in
developing and maintaining quality programs that adhere to both company standards and external
regulations. This role will support internal and external audits, change control, quality management systems,
and quality improvement/investigations.
*This role requires adapting to a hybrid working environment, where you will have the opportunity to
work both remotely and on-site, ensuring effective collaboration and flexibility while contributing to
the team's success.
Duties & Responsibilities
- Support development and implementation of Quality Programs to ensure adherence to standards, regulations, policies, and procedures of services offered by the company.
- Monitor all QA processes contributing to the performance of the company.
- Conduct auditing activities to ensure that studies are conducted in accordance with client protocols, GCP, industry guidelines, agency regulations.
- Actively participate in activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits.
- Troubleshoot and identify non-conformance activities, provide suitable recommendations, and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and/or ISO standards where applicable.
- Conduct vendor audits and work with vendor personnel in eliminating problems via root cause analysis techniques. Review vendor supplied data and quality records for conformance and good documentation practices (GDP).
- Contribute to the development, implementation, and execution of a training curriculum.
- Assist the company in ISO9001, ISO17025 and other Certification activities.
- Manage and maintain databases for the Quality system.
- Prepare and assist in preparing annual reports and quality trending reports.
- Contribute to QA continuous improvement programs and report the status of the quality levels of staff and systems to the Manager, QA. Communicate any critical compliance risks noted from activities to senior management.
- Keep up to date with all related regulatory legislation and compliance issues.
- Bachelor’s degree of equivalent in life sciences or related field with demonstrated experience in the Pharmaceutical or Clinical Research and:
- In-depth knowledge of International regulatory standards in Clinical Research.
- Experience of working with Quality System and knowledge of ISO Standards.
- Must be results oriented with the ability to multi-task and respond to the urgent needs of the team.
- Effective time management, organizational, and communication skills.
- Ability to work independently and adapt to changing priorities.
- High level of integrity and accountability.
- Proficient in computer skills with the inclination to adopt technology to maximize efficiency.
- Experienced in Quality Management System.
- ISO9001 and ISO17025 experience is a plus.
- Experience in clinical/laboratory audit.
- Prior participation in external audits/accreditation.
