Quality Control Manager

Berko İlaç ve Kimya San. A.Ş.

About Us

Serving with 127 products and nearly 800 employees, Berko Pharmaceuticals, manufactures for a healthy future. With 21,000 square meters of indoor space and 142 million boxes of annual production capacity, Berko Pharmaceuticals, Manufacturing Site operates at GMP standards and is registered by the FDA for supplementary food products

Qualifications, experience, knowledge & skills required

• At least a Bachelor's degree in a scientific field chemistry or chemical engineering
  
• Thorough knowledge of QC systems/areas with a minimum 10 years managerial experience
  
• In-depth knowledge of quality control procedures and legal standards.
  
• Practical experience of Good Manufacturing Practice c(GMP) and Good Laboratory Practise (GLP) and their applications
  
• Application and knowledge of risk management strategies
  
• Demonstrable leadership skills
• Excellent planning, organisational and prioritisation skills
  
• Effective written and oral communication skills at individual, team, and organizational levels
  
• Demonstrates capability as a visionary for on-going continuous improvement
  

Key Responsibilities

• Ensuring maximum cooperation and communication between Quality Control and other departments to ensure optimum performance levels consistent with the realization of business plans
  
• Review, manage and optimise the performance of staff and resources
  
• Devising, improving, and reviewing procedures for products or processes, and training staff to use them
  
• Overseeing production procedures to identify any deviations from quality standards
  
• Implement and manage QC related SOPs and processes
  
• Monitor data integrity, SOPs, specifications, methods, cGMP through real time verifications of records
  
• Participates in regulatory audits, inspections, Quality teams, and site committees. Interact with other business units and other plant sites to address issues affecting the laboratory
  
• Oversee and manage company’s stability program as per regulatory guidelines
  
• Reviews, evaluates, and manages projects to improve Quality Operations compliance status, overall laboratory operational efficiency and stability program
  
• Contribute in preparation and monitoring of budgets through regular analysis of cost and spending
  
• Accountable for assuring all laboratory data are generated and approved under the current regulatory, GMP, and corporate guidelines
  
• Establishes laboratory team objectives, sets testing priorities, and coordinates laboratory resources to align with objectives
  
• To provide effective communication with other departments about the progress of quality control activities
  
• Responsible for assuring laboratory personnel are qualified through proper training on appropriate departmental and site SOPs, training modules, cGMP, Quality Alerts/ Guidelines/Policies/Procedures, and Quality Standards