Description
QA Compliance/Change Control Expert 6- 12 months contractThe goal for this position is to support and ensure 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:
- 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, Corporate Quality Manual, policies and cost effectiveness
- 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 (on-site and off-site) 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 ensure timely delivery of complete and consistent source data
- To coordinate and provide timely review (on-site) of CMC documentation
- To ensure that projects are realized/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 main and sub pro-cesses (e.g. CAR, capacity planning, resources, etc.)
- To support training and development of on-site personnel with regards to skills and capabilities required for change project management
Experience requirement:
Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles / Biotechnology
Profound knowledge of cGMPs
Proven track record with FDA, EMEA and other Health Authorities.
Strong understanding of risk assessment and risk management fundamentals/tools
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.