4 Qc Documentation Jobs

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.

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

Good knowledge of QMS, Change control , Deviation. Having knowledge of Validation, APQR and other qulaity complience..Responsibilities: Perform analytical testing using various techniques, including HPLC, GC, UV-Vis, FTIR, and other relevant methods. Prepare and standardize solutions and reagents. Analyze and interpret test results, ensuring accuracy and compliance with specifications. Document all testing activities and results in accordance with GMP/GLP guidelines. Maintain and calibrate laboratory equipment. Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPA). Prepare and review QC documentation, including SOPs, test methods, and reports. Participate in internal and external audits. (Senior Analyst) Provide technical guidance and training to junior analysts. (Senior Analyst) Assist in method development and validation.

To get GA drawing approval from client in consultation with V TOP& Marketing Execute DQ. Documentation of project,tracking &reporting of project status report Update Brahma& reports, collect all reports like kick off Updating Drawing approval report Required Candidate profile Co-coordinating with factory & marketing team Co-ordination of activities between design, planning, material production and vendor management Keeping track of short supplies Updating PLC FDS