Commercial Quality Specialist - 2011783 Description Support the Commercial Operations in supplying product to our Customers in compliance with all the regulatory requirements such as GMP and GDP and in implementing and maintaining a local quality management system for GMP / GDP compliant to all the pertinent internal policies and SOPs (local / global / divisional).
Accountabilities 1. QUALIFICATION AND VALIDATION MANAGEMENT Local Management System Owner (L-MSO) for Transport and Distribution in order to ensure that systems and equipment are in appropriate validated status and under adequate control (calibration and maintanance plan) and to ensure a periodic review of the performance of the distribution system through the continuous transport verification.
2. COMPLAINTS AND DEVIATION MANAGEMENT management of technical product complaints (TPC) and deviations raised during qualification and validation management and during continuous transport verification.
Management of TPC and deviation in Trackwise, assuring that all cases are entered and followed-up according to the relevant Corporate guidance.
3. MANAGEMENT OF RISK ASSESSMENT Local Management System Owner (L-MSO) for the risk assessment in order to guarantee the compliance to ICH Q9 and Corporate Guidelines.
4. CHANGE CONTROL MANAGEMENT Deputy of L-MSO for the management of change control and their regular follow up. Support L-MSO in issuing and close assigned tasks within expected due dates.
5. MANAGEMENT AND UPDATING OF X-FREE DECLARATIONS Requirements Implementing / revising relevant GMP / GDP quality systems related to commercial product supply to meet the continual needs of BI and the local authorities and ensure that products and processes / systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.
Eligibility Requirements GMP / GDP adoption& interpretation , Regulatory knowledge, Team Working, Negotiation skill, Communications skill, Client-oriented approach, ability to listen and investigational ability.