Executive & Senior Executive- Quality Control (RM & AMV)

Job Description

We are hiring for the following 2 positions: Senior Executive- Quality Control RM Section Head- 5-8 Years of Experience Executive- Quality Control- Analytical Method Validation- 4-6 Years of Experience 1. Senior Executive- Quality Control- RM (Raw Material) Section Head Raw Material Testing and Release: Supervise and ensure the testing of raw materials (active pharmaceutical ingredients, excipients, packaging materials) according to approved specifications. Lead the RM team in the timely testing and release of raw materials for production use, ensuring no delays in manufacturing. Ensure that the testing of raw materials is compliant with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and other relevant regulatory standards. Supervision and Team Management: Lead, guide, and mentor a team of QC analysts in the RM section, ensuring effective training and development. Allocate tasks and manage workload distribution within the team to ensure smooth and efficient operations. Conduct regular performance appraisals, set objectives, and ensure team productivity and morale. Raw Material Specifications and Documentation: Review and ensure the accuracy and completeness of raw material specifications, test protocols, and related documents. Approve the testing methods and ensure compliance with the established standard operating procedures (SOPs). Ensure the proper maintenance of records related to raw materials, including stability studies, inventory control, and release certificates. Compliance and Regulatory Adherence: Ensure all raw materials and testing activities comply with the Indian Pharmacopeia (IP), USP, BP, and other regulatory standards. Ensure that all QC raw material processes are aligned with FDA, EMA, and other regulatory guidelines as applicable. Assist in audits (internal and external), and provide necessary data and reports during regulatory inspections. Equipment and Instrument Management: Oversee the calibration, maintenance, and qualification of equipment used in the RM section, ensuring accurate and reliable results. Ensure that the laboratory instruments and equipment are well-maintained and functioning optimally. Quality Control & Troubleshooting: Address any deviations, out-of-specification (OOS) results, or out-of-trend (OOT) findings related to raw material testing. Investigate and resolve any quality control issues, and recommend corrective and preventive actions (CAPAs). Lead root cause analysis and support the investigation of quality incidents related to raw materials. Vendor Management & Raw Material Supplier Interaction: Liaise with suppliers and vendors to ensure the timely and quality supply of raw materials. Participate in the selection and qualification of raw material suppliers and ensure they meet quality standards. Continuous Improvement and Efficiency: Identify opportunities for process optimization and recommend improvements to enhance operational efficiency. Ensure that the QC RM section continuously adheres to cost-effective practices, reducing wastage and improving turnaround time. Training and Knowledge Sharing: Train QC team members on analytical techniques, equipment usage, and quality control standards for raw material testing. Keep the team updated on industry trends, new regulatory guidelines, and best practices. Executive-Quality Control- Analytical Method Validation (AMV) Analytical Method Validation (AMV) : Conduct validation of analytical methods as per ICH, FDA, and other regulatory guidelines. Perform method development, optimization, and validation for raw materials, in-process materials, and finished products. Ensure adherence to validation protocols and documentation. Testing & Documentation : Oversee the execution of analytical testing for stability, release, and in-process samples. Review and verify analytical data, ensuring accuracy and completeness. Prepare and review validation reports, SOPs, and other related documentation. Compliance & Quality Assurance : Ensure compliance with GMP, GLP, ISO, and other relevant standards in laboratory activities. Support the QC team in audits (internal and external) and address any non-conformities. Ensure proper handling, storage, and disposal of chemicals, reagents, and samples in compliance with safety protocols. Equipment Maintenance : Coordinate with the maintenance team for the calibration and qualification of laboratory instruments. Perform routine checks and calibration of instruments used in testing and validation. Continuous Improvement : Actively participate in continuous improvement initiatives and training programs. Suggest and implement improvements in analytical methods and processes to enhance efficiency. Cross-Department Collaboration : Liaise with R&D, production, and regulatory teams to resolve technical issues. Assist in troubleshooting analytical issues in collaboration with the technical team