Pharma quality incharge

The pharmaceutical Quality Control (QC) professional ensures that drugs and related products meet quality standards throughout their lifecycle, from raw materials to finished goods. This involves a range of activities including testing, analysis, and documentation, all while adhering to regulatory guidelines and company procedures. Key Responsibilities: Testing and Analysis: Conducting various tests on raw materials, in-process samples, and finished products using analytical techniques like HPLC, GC, UV, and spectroscopy. Quality Standards Compliance: Ensuring products meet established quality standards, specifications, and regulatory requirements (e.g., GMP, ICH, USFDA, WHO). Documentation and Reporting: Maintaining detailed records of all testing, analysis, and investigations, including preparing certificates of analysis and other relevant reports. Equipment Management: Calibrating, maintaining, and troubleshooting analytical instruments and equipment. Deviation Investigations: Investigating and documenting any deviations from established quality standards or procedures (e.g., Out of Specification (OOS) results) and implementing corrective and preventive actions (CAPA). Stability Studies: Conducting and documenting stability studies to assess product shelf life and storage conditions. Method Validation: Validating analytical methods to ensure they are suitable for their intended use. Training and Supervision: Training and supervising QC technicians, ensuring they adhere to quality standards and procedures. Audits and Inspections: Participating in internal and external audits and inspections, addressing any findings, and ensuring compliance. Inventory Management: Managing the inventory of reagents, standards, and other materials needed for QC analysis. Process Improvement: Identifying opportunities to improve the efficiency and effectiveness of QC processes. Skills and Qualifications: Education: Typically requires a Bachelor's or Master's degree in Chemistry, Biochemistry, Microbiology, or a related field. Analytical Skills: Strong analytical and problem-solving skills, including the ability to interpret data, troubleshoot issues, and make informed decisions. Technical Skills: Hands-on experience with relevant analytical techniques and instrumentation. Regulatory Knowledge: Understanding of cGMP, ICH guidelines, and other relevant regulatory requirements. Attention to Detail: Meticulous attention to detail is crucial for accurate testing, documentation, and investigations. Communication and Interpersonal Skills: Ability to effectively communicate with team members, management, and other stakeholders. Problem-solving skills: Ability to identify the root cause of quality issues and implement effective corrective actions.,