Position Details

This role is responsible for overseeing the laboratory and QC team, planning workload, procedures and testing to ensure acceptable product quality.

KEY RESPONSIBILITIES
• Responsible for the laboratory, including stability, retention, safety, cleanliness and order. 
• Schedules and assigns all activities and ensures they are completed on time. 
• Trains department staff to comply with GMP/GLP regulations and company policies. 
• In accordance with the current Monographs, examines and reviews the results of the analytical tests of the finished products, ensuring their integrity and compliance with the registered specifications. 
• Responsible for assembling the analytical package of batches and delivering it to the site QP for the release of the product batches. 
• Issues analytical certificates of the production batches and submit them to the QP for review. 
• Reviews and approvals all documents for release of materials for production use. 
• Check and control the lab metrics to ensure all KPIs are met. 
• Responsible for writing stability protocols and ensuring that stability tests are performed on time and according to the stability protocol. 
• Responsible for lab investigations and deviations, their execution with the application of the DMAIC     method, their opening and management with requested timing. 
• Prepares and reviews procedures, monographs, analytical methods and ensures that all department GMP     documents are updated according to other departments documentations, applicable regulations and company     policies. 
• Responsible for the good condition and efficiency of all equipment lab, ensures that all equipment and instruments used for analyses are qualified and within a periodic maintenance plan. 
• Supports the qualification of new materials/suppliers and process validations with analytical tests. 
• Responsible for the evaluation of analytical data, preparation of annual trends and definitely of control limits for key analytical parameters, as part of the preparation of annual product review.
• Actively participates in external and internal audit. 
• Works in collaboration with other departments including production, engineering and QA to achieve common site goals. 
• Other duties as assigned. 

KEY COMPETENCIES, REQUIREMENTS, COMPLEXITY
• Good knowledge of GMP regulations
• Strong communication, management and multitasking skills. 
• Good oral and written English. 
• Planning and organizational skills, including developing successful teams. 
• Ability to independently solve problems. 

EDUCATION, KNOWLEDGE, YEAR OF EXPERIENCE
• Bachelor’s degree in chemistry/biology/chemistry and Pharmaceutical Technologies. 
• At least 2 years of experience in QC testing including HPLC tests and GC.