Job
Description
As a Stability Study Manager, your role involves managing and overseeing stability study processes to ensure compliance with regulatory requirements and maintain the integrity of stability data. You will coordinate stability analyses, handle audits, and support quality management systems (QMS) to uphold the highest standards of quality and compliance. Key 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 for regulatory submissions and manage audits and responses related to stability. - Review and approve stability data to ensure compliance with standards. - Review, issue, and retrieve Standard Operating Procedures (SOPs) following established protocols. - Prepare 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 and perform studies according to ICH guidelines and medical device regulations. - Manage Quality Management System (QMS) activities, including deviations, change controls, market complaints, and CAPA. Qualifications Required: - Master's degree in pharmaceutical sciences, chemistry, biotechnology, or a related field. - 2-4 years of experience in stability studies within the pharmaceutical industry. - Proven ability and experience in drafting stability protocols. - In-depth knowledge of ICH guidelines and other relevant regulatory requirements. - Experience with quality management systems, including deviation, change control, CAPA, and market complaints. - Strong analytical skills with the ability to perform gap assessments and investigations. - Excellent communication skills, both written and verbal, with a strong attention to detail. As an individual contributor in this role, you will report to the Senior Manager QC. As a Stability Study Manager, your role involves managing and overseeing stability study processes to ensure compliance with regulatory requirements and maintain the integrity of stability data. You will coordinate stability analyses, handle audits, and support quality management systems (QMS) to uphold the highest standards of quality and compliance. Key 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 for regulatory submissions and manage audits and responses related to stability. - Review and approve stability data to ensure compliance with standards. - Review, issue, and retrieve Standard Operating Procedures (SOPs) following established protocols. - Prepare 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 and perform studies according to ICH guidelines and medical device regulations. - Manage Quality Management System (QMS) activities, including deviations, change controls, market complaints, and CAPA. Qualifications Required: - Master's degree in pharmaceutical sciences, chemistry, biotechnology, or a related field. - 2-4 years of experience in stability studies within the pharmaceutical industry. - Proven ability and experience in drafting stability protocols. - In-depth knowledge of ICH guidelines and other relevant regulatory requirements. - Experience with quality management systems, including deviation, change control, CAPA, and market complaints. - Strong analytical skills with the ability to perform gap assessments and investigations. - Excellent communication skills, both written and verbal, with a strong attention to detail. As an individual contributor in this role, you will report to the Senior Manager QC.
