Senior Quality Assurance Specialist
1 day ago
Job Description
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. The ideal candidate will have expertise in clinical research operations and a background as a Clinical Research Associate (CRA) with experience in pharmaceutical companies or Contract Research Organizations (CROs).
This role involves working closely with clinical operations and regulatory teams to ensure compliance with Good Clinical Practice (GCP) and relevant industry standards. Key responsibilities include:
- Implementing and managing the quality management system (QMS) within clinical operations.
- Ensuring adherence to GCP, Standard Operating Procedures (SOPs), and regulatory requirements.
- Overseeing data quality from clinical trials, ensuring accuracy and consistency.
- Conducting quality control audits of trial sites, identifying gaps and recommending corrective actions.
Requirements
To be successful in this role, you will need:
- A Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Advanced degree (Master's or PhD) or equivalent experience in clinical research or pharmaceutical quality management.
- A minimum of 5 years of experience in clinical research, focusing on quality assurance or quality management.
- Experience as a CRA, ideally within a pharmaceutical company or CRO.
- Strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
- Proven experience auditing clinical trial sites and implementing corrective actions.
- Strong communication, analytical, and problem-solving skills.
- Ability to work collaboratively in cross-functional teams.
Compensation
The estimated salary for this position is R1,200,000 per annum, commensurate with experience. A comprehensive benefits package includes medical aid, life insurance, and annual performance bonuses.
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