Executive stability study handling

3 weeks ago

Ahmedabad, India Biotech Healthcare Full time

Role Objective: To manage and oversee the stability study processes, ensuring compliance with regulatory requirements and maintaining the integrity of stability data. Role involves coordinating stability analyses, handling audits and supporting quality management systems (QMS) to ensure the highest standards of quality and compliance are met. Desired Candidate Profile: Master's degree in Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field. 3-5 years of experience in stability studies within a pharmaceutical or medical device 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. Role & 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. Functional Skills Required: 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. Behavioral Skills Required: Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. High attention to detail with the ability to manage complex tasks under pressure. Proactive in identifying and resolving quality-related issues. Commitment to continuous improvement and operational excellence. Team Size to be Handle: Individual Contributor role, reporting to Senior Manager QC. Learn more at: Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

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