Pharmaceutical Stability Study Manager
6 days ago
At Biotech Healthcare, we are seeking an experienced Pharmaceutical Stability Study Manager to join our team. In this role, you will be responsible for overseeing the stability study processes and ensuring compliance with regulatory requirements.
Responsibilities:
- Coordinate with the Quality Control team for stability analysis and retrieval of stability data.
- Prepare stability study protocols and conduct gap assessments in stability analysis.
- Arrange stability samples and conduct daily reviews of temperature and relative humidity (RH) printouts.
- Provide stability data as required for regulatory submissions and handle audits and responses related to the stability section.
- Review and approve stability data to ensure compliance with standards.
- Review, issue and retrieve Standard Operating Procedures (SOPs) in accordance with established protocols.
- Prepare pre- and post-execution qualification and validation documents, as well as summary reports for stability studies.
- Support quality-related customer complaint investigations and trend analysis activities.
- Conduct investigations for any stability failures.
- Perform stability studies in accordance with ICH guidelines and medical device regulations.
- Manage Quality Management System (QMS) activities, including handling deviations, change controls, market complaints, and CAPA.
Requirements:
- Proficiency in stability study management, including sample handling, data review, and protocol development.
- Expertise in regulatory compliance, especially ICH guidelines and medical device regulations.
- Strong technical skills in qualification and validation of stability chambers.
- Competency in quality management systems, including deviation, change control, CAPA, and market complaints.
Salary: $80,000 - $120,000 per year, depending on experience. We offer a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
We are an equal opportunity employer and welcome applications from diverse candidates. Learn more about our company culture and values at [website URL].
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