Change Control Specialists (Qua007081)

Careerwise Recruitment

Cork

CHANGE CONTROL SPECIALIST required by CareerWise Recruitment for our multinational pharmaceutical / BioTech client in Co. Cork. The CHANGE CONTROL SPECIALIST role will involve progressing and reviewing change control documentation from all areas on site. THE ROLE: * Position will involve progressing and reviewing change control documentation from all areas on site. * Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision. * When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, for the most efficient way of progressing proposed change with minimum disruption to the site. * Review change control documentation received for clarity, ensuring relevant supportive data has/ will be generated. * Confirm categorisation of site change control. * Establish productive working relationships with colleagues within project teams at site and other regulatory / change control subsidiaries. * Link in with site Change Owners in terms of what change control would need to be reviewed by CMC regulatory personnel to determine impact to Clinical / commercial licenses for proposed changes. * Provide Change control support as required during HA inspections. * Provide change control training to the site for change originators and reviewers of proposed changes. * Leverage off the network in terms of change control guidance and support for biologics and vaccines when required. * Provide guidance and support to the site in terms of change control business processes and systems. * Support the application and management of site licenses and GMP certificates. * Update manufacturing authorization to ensure that site documentation is in line with approved registrations. * Carry out annual product reviews from Change Control Perspective. * Project management skills. REQUIREMENTS: * Degree in Biological Sciences, Biochemical engineering or related discipline. Advanced degree preferred. * Min 3-5 Years biological experience in Regulatory / Technical / QA experience in biological research, development and / or manufacturing. Please call Conor Twomey today for further information on 021-4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2159 days ago