QA Compliance Manager -Change Control 6 months contract
We have a new contract opportunity for an experience quality assurance expert to focus on change control activities according to GMP regulations. There is a chance to extend the contract further.
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, Corporate Quality Manual,
To establish and support on site project teams in order to ensure project management ac-cording 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 REG CMC) 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 co-ordinate 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 processes
To support training and development of on-site personnel with regards to skills and capabilities required for change project management
Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products 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 email your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.