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Team Leader
2 weeks ago
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents, create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees. **Job Summary/Main Purpose** The Process/Project Lead in the Quality Control division is responsible for overseeing and leading quality control processes and projects within the department. This role ensures that products meet quality standards and regulatory requirements. The main purpose of this position is to optimize processes, manage QC projects, and lead a team of QC professionals. The Process/Project Lead will develop, implement, and maintain QC processes to improve efficiency and product quality, analyze current QC processes to propose improvements, and coordinate with cross-functional teams including R&D, regulatory affairs, production, and compliance. Additionally, the role involves conducting audits and inspections to maintain compliance with regulatory requirements, leading and mentoring QC staff, analyzing quality data to identify trends and areas for improvement, and preparing and presenting reports on QC activities and project progress to management. **Key Responsibilities** - Responsible for overseeing and leading quality control processes and projects within the department, ensuring that products meet quality standards and regulatory requirements. The role involves process optimization, managing QC projects, and leading a team of QC professionals. - Develop, implement, and maintain QC processes to improve efficiency and product quality. - Analyze current QC processes and propose improvements to optimize performance. - Coordinate with cross-functional teams, including R&D, regulatory affairs, production, and compliance. - Ensure that all products meet internal and external quality standards. - Conduct audits and inspections to maintain compliance with regulatory requirements. - Lead, train, and mentor QC staff to ensure a high level of competency and motivation. - Analyze quality data to identify trends and areas for improvement. - Prepare and present reports on QC activities and project progress to management. - Ensure adherence to industry regulations and standards (current regulatory & cGMP requirements). - To adhere with the cGMP principles (premises, personal, equipment, documentation, QMS and audit) and to maintain them in an effective manner. - To check and ensure proper usage of all the QC equipment. - To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis. - To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis. - To ensure the analysis is performed correctly as per applicable procedures and the raw data is checked for correctness, accuracy and compliance. - To perform investigation for the lab incidents, OOS, OOL results, deviations and take appropriate corrective and preventive actions. - Follow up &close all the EQMS actions (CAPA, OOS, Deviations, CC) - To involve and support external and internal audits and to close the audit observations on time. - To handle and close the Quality management system actions like Deviations, OOS, CAPAs, AMS and Change controls using Amplelogic system. - To follow and ensure data integrity and good documentation practices are implemented in the QC labs. - To ensure and follow GLP, GMP, safety procedures and maintain hygienic conditions in lab. - Shall be authorized as designee for responsibilities of QC Sr Manager. - Apart from the above, the works assigned by the Head of the department/designee. **Core Competency** - In terms of Competency, you are highly oriented with a strong sense of accountability & ownership, - Excellent communication, interpersonal and presentation skills. - Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan - Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities, an analytical mind able to "see" the complexities of procedures and regulations - Strong Manpower handling skills and having effective team communication and motivational skills. - Capable of suggesting ideas in a structured manner and having good C
