Quality Compliance Manager- change control

Beschreibung

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.

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, 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

Experience requirement:

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.