Manager Quality control

You should have 16-20 years of experience in the pharmaceutical industry and be located in Pithampur. A degree in M.Sc./ M. Pharma / B. Sc. / B Pharma is required for this position. Your responsibilities will include daily planning of analytical activities, resource management, and work allocation. You will be responsible for planning and executing sampling and analysis for raw materials, packaging materials, intermediates, and finished products. You will review and/or approve the implementation of standard operating procedures, analytical protocols, and analytical reports. Additionally, you will review and/or approve the qualification and calibration of instruments. You will investigate and review laboratory events, out-of-specification (OOS) results, out-of-trend (OOT) results, and deviations. Ensuring compliance with QC-related electronic data management, such as computer system validation, electronic data backup, storage, and retrieval, will be part of your role. You will conduct training sessions to enhance the analytical skills of quality control personnel. Managing procurement and inventory control of materials and equipment required for QC activities will be essential. You will review analytical activities related to process validation, cleaning validation, and analytical method validation. You will have the authority to release raw materials, intermediates, stability samples, and working standards in the absence of the QC Head through the Laboratory Information Management System (LIMS). Monitoring non-routine activities such as stability studies, working standard management, calibration management, and analytical method transfer/verification will also be part of your responsibilities. You will be the responsible person for all QC activities in the absence of the Head QC. Desired skills for this position include experience in facing various regulatory inspections like USFDA, MHRA, EMA, and TGA. Experience in auditing finished dose formulation units, API and Intermediate/KSM vendors is preferred. Experience of working in an API unit is a plus. You should have excellent functional knowledge and application skills, a proactive approach to internal and external queries, and the ability to manage multiple stakeholders. High standards of business ethics, excellent communication skills, and strong decision-making skills are essential for this role.,