Job
Description
We are seeking a meticulous and experienced Manager Quality Control to lead and enhance our quality control operations at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in overseeing all aspects of quality control, ensuring adherence to Good Laboratory Practices (GLP), and maintaining a robust Quality Management System (QMS). Your expertise will be crucial in driving Analytical Method Development, managing CAPA and Change Control processes, and upholding Data Integrity standards. You will lead a team of QC analysts, providing training and mentorship to foster a culture of excellence. The ideal candidate will possess a strong understanding of ICH Guidelines and Regulatory Compliance, with hands-on experience in GC and HPLC. This role demands a proactive approach to QC process improvement, meticulous QC documentation, and the ability to conduct thorough analytical data reviews. Job Details: Industry: Active Pharmaceutical Ingredient (API) Department: Quality Control Role: Manager - Quality Control Location: Visakhapatnam Compensation: 12 -15 LPA Experience Required: 10 - 15 years Employment Type: Full-time Required Qualification: Bachelor's degree in Chemistry, Pharmacy, or a related field Responsibilities: Analytical Method Development and Validation Lead the development, validation, and transfer of analytical methods for API testing in compliance with ICH and regulatory requirements. Review validation protocols and reports, ensuring accuracy and completeness. Troubleshoot analytical challenges and provide technical guidance. Collaborate with AR&D to optimize methods for both new and existing products. Ensure complete documentation of method development and validation activities. Quality Management System (QMS) and Compliance Maintain and improve the QMS to comply with regulatory standards (US FDA, EU GMP). Oversee CAPA and Change Control processes to address quality deviations. Conduct internal audits to ensure procedural compliance and identify improvement areas. Ensure adherence to Data Integrity principles across QC operations. Serve as the key QC contact during regulatory inspections and audits. Laboratory Operations and Equipment Management Supervise daily QC laboratory operations and ensure efficient sample testing. Oversee calibration and maintenance of laboratory instruments (GC, HPLC). Monitor lab environmental conditions and implement corrective actions where needed. Ensure sufficient availability of reagents, standards, and consumables. Implement lab safety procedures and optimize workflows to improve turnaround time. Team Leadership and Performance Management Lead and mentor QC analysts, fostering a collaborative and improvement-driven culture. Conduct performance evaluations and provide development-focused feedback. Design and deliver technical training programs to enhance team capability. Assign responsibilities to ensure a balanced workload and accountability. Address employee concerns and promote a positive, inclusive work environment. Data Analysis and Reporting Oversee review and interpretation of analytical data for compliance and reliability. Approve QC reports including Certificates of Analysis (CoAs). Identify trends and take proactive measures to address quality concerns. Present QC metrics and insights to management and cross-functional stakeholders. Maintain accurate records and use statistical tools to evaluate data. General Expectations and Past Experiences: Strong understanding of pharmaceutical QC principles and global regulatory standards (US FDA, EU GMP). Demonstrated expertise in analytical method development and validation with hands-on experience in GC and HPLC. Proven track record of maintaining QMS aligned with ICH guidelines. Experience managing CAPA, Change Control, and Deviation processes. Deep commitment to Data Integrity and documentation compliance. Strong leadership skills with a track record of mentoring high-performance teams. Excellent interpersonal, communication, and analytical problem-solving abilities.
