Site Change Coordinator

Sandoz İlaç San. ve Tic. A.Ş.

As Novartis Technical Operations, we are looking for a Site Change Coordinator that will be responsible from the following processes:

• To support and ensure consistency and implementation of assigned change projects (including transfers, divestment, pruning and due diligence activities) end to end, in order to ensure timely implementation of changes and supply to the markets in compliance with regulatory and cGMP requirements.
• Accountable to drive and coordinate on-site and inter-functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, cGMP’s, regulatory requirements, Corporate Quality Manual, Novartis policies and cost effectiveness.
• To set priorities for change requests at a site level in line with the relevant boards.
• To support on site project teams in order to ensure project management according to the agreed strategy and timelines
• To ensure efficient, timely and clear communication to all involved partners (on-site and off- site incl. to global product lifecycle leader and RA CMC) as required for flawless project execution in collaboration with project leader
• To communicate project progress and deviations as appropriate in collaboration with project leader, when available.
• To elaborate risk mitigation plans as appropriate in collaboration with project leader
• To solicit input from site functions and to ensure that site specific information is made available in global projects and in relevant databases
• To coordinate availability and timely review (on-site) of CMC documentation
• Needs to ensure that assessment of supply is performed.
• University or academic degree in Chemistry, Biology, Pharmacy or equivalent Local language and English Several years of experience in chemical/pharmaceutical industry, QA/production experience is beneficial advantage: experience in production/QA/QC.