Job
Description
We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.
