Quality Control Physico-Chemical Manager

The Quality Control Physico-Chemical Manager is responsible for management of the Physico-Chemical team in the scope of tasks related to the analytical tests of final products, intermediate products, raw materials and packaging materials. Implementation of new methods in the subordinate team, coordination of works related to the transfer, validation and qualification of analytical methods. Coordination and implementation of tasks related to the quality projects. Quality Control Physico-Chemical Manager reports directly to the Head of Quality Control.
 

• Building of a pharmaceutical quality system, qualification of control and measurement equipment, preparation for GMP certification - applicable to the design phase;
• Supervising and coordinating the timeliness of analytical work related to the product manufacturing process and the transfer of methods and the qualification of analytical methods in the subordinate team;
• Conducting regular meetings of the Team and conducting periodic employee evaluation;
• Conducting lab investigations (OOS, OOE, OOT, and complaints for product quality) and associated corrective and preventive actions;
• Participation in developing or reviewing Instructions and Procedures, including test methods and Operating Instructions;
• Participating in change control processes;
• Ensure correctness of analytical documentation. Implement continuous improvement activities, as needed, to ensure right the first time documentation by the subordinate Team;
• Participation in internal and external audits and implementation of post-audit recommendations;
• Compliance with GMP, health and safety, and fire protection regulations;
• Assignment of tasks/duties and coordinating the schedules of subordinate employees;
• Finding new solutions for better planning and organization of work in the team. lmproving efficiency and safety at the workplace. Developing the Lean and 6s culture. Introducing and improving upon key performance indicators (KPI) in the team in order to minimize costs and losses;
• Implementation of the subordinate team's initiatives to improve GMP compliance, organizational structure, technical competency, and compliance with fire/safety rules;
• Identification and evaluation of contract laboratories for external testing;
• In consultation with the Head of the Quality Control Department, ensuring appropriate level of staffing and qualifications of employees;
• Responsibility for maintaining the cost levels within the approved annual budget of the Company by analyzing the individual components of costs and optimizing activities, and is involved in the budgeting of the QC Department.

• Higher education, with a specialization in the fields: biotechnology, biology, chemistry or related;
• Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 5 years);
• Familiarity with chromatographic techniques;
• Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines;
• Ability to communicate effectively internally within QC and external teams.
• Basic knowledge of statistical analyses;
• Ability to set priorities and multi-task;
• Ability to independently develop work schedules and operational plans;
• Very good command of English language (written and spoken).

• Competitive salary; 
• Private healthcare;
• Life insurance;
• Pension plan above national standards;
• Relocation package;
• Additional free day;
• and more..