Team Leader - Quality Control

Job Summary/Main Purpose

The Finished Product & Stability Team Leader at Julphar HQ leads quality control processes and a team within the Quality Control division, ensuring compliance with regulatory standards, managing inspections, audits, data analysis, and staff training.

• Responsible for the planning and supervision of all QC finished products and stability team and maintain online compliance in all activities.
• Operate various Quality Control (QC) instruments and equipment, depending on the assigned section.
• Ensure adherence to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and safety procedures while maintaining a clean and hygienic laboratory environment.
• Enter, review, and verify test data on the SAP system.
• Prepare, review, and update Standard Operating Procedures (SOPs) related to finished product and stability testing and inspection activities.
• To coordinate with Production plants for planning analysis.
• Handling and supervision of Technology transfer projects.
• Supervise and follow up with analysts in the finished products and stability team to ensure accuracy, compliance, and timely completion of activities.
• Responsible for the release or rejection of finished products and stability in SAP according to quality evaluation results.
• Coach, guide and train the team to ensure a high level of competency and motivation.
• Analyze quality data to identify trends and areas for improvement.
• 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 premises and equipment.
• 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.

• Apart from the above, the works assigned by the Head of the department/designee.
• 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.

• In terms of competency, 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 Command on English language.
• High on communication and collaboration, having an ability to manage multiple stakeholders at a time.
• Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view.
• In-depth knowledge of the industry’s standards and regulations guidelines, excellent knowledge of reporting procedures and record keeping.
• Must be able to manage tasks and priorities and easily adapt to changing situations.
• Ability to create cross functional relations and manage conflicts.
• Problem Solving and high agility on taking right scientific decisions.

• Minimum 7 years of experience in QC/QA department.
• Must be experienced in managing complex and sensitive operational challenges.
• Bachelor’s degree in pharmacy
• Proven experience in quality control, having leadership skills.
• Strong knowledge of regulatory requirements and quality standards relevant to the industry.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong leadership and team management capabilities.