We are recruiting for an experienced quality assurance expert with focus on change control review and investigation. You will be supporting the quality team in ensuring the consistency and implementation of assigned change projects (including transfers, divestment, pruning and due diligence activities) from initiation to execution, in order to ensure timely supply to the markets in compliance with regulatory and cGMP requirements. Major Activities: Support Change Control Coordinator onsite
To lead the on site and inter functional evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities, cGMP’s, regulatory requirements.
To establish and 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 as required for flawless project execution in collaboration with project leader To communicate project progress and deviations as appropriate. 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 and provide timely review of CMC documentation To ensure that projects are implemented without stock outs. To ensure that write-off costs are kept to a minimum To support process experts in evaluation, planning and execution for tasks
To support training and development of onsite personnel with regards to skills and capabilities required for change project management.
Experience/Professional requirement and skills:
Solid experience in Quality Control / Quality Assurance in the manufacturing of pharmaceutical drug products for Sterile or Biotechnology area. Profound knowledge of cGMPs Proven track record with FDA, EMEA and other Health Authorities. Strong understanding of risk assessment and risk management fundamentals/tools
This is 6 months contract , based in the manufacturing site in Switzerland.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.