Quality Assurance Specialist X2 Job in Cork Ireland
CPL Cork has been retained by one of their key clients to partner in the sourcing and selection of 2 Quality Assurance Specialists
Position Description and Responsibilities
· This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to JJ projects as required by Good Manufacturing Practice (GMP). ?
· These activities include review and approval of change controls, nonconformance investigations, and protocols.
· Primary Tasks and Responsibilities ?
· Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the JJ Standard of Leadership behaviour model.
· Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. ?
· Supports the management of GMP compliance systems through the following activities:
Assess compliance systems on ongoing basis to identify opportunities for process improvement.
Carries out tasks related to the administration of project and site non-conformance management systems: Reviews and/or approves non-conformance investigations and their associated documentation.
Manage entry of non-conformance records into the appropriate electronic system.
Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions.
Carries out tasks related to the management of project and site change control systems:
Reviews and/or approves change control requests, implementation actions, and request closures. Manage entry of change control records into the appropriate electronic system.
Qualifications and Experience Essential
• Bachelors Degree in a scientific/technical discipline required
• A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry
• Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
If you are interested in hearing more about this opportunity, please call Rory Walsh, Senior Recruitment Consultant, for a confidential discussion on 021 4626112, or send your cv to rory.walsh@cpl.ie .
If you are not interested in this role but you would like to hear about future opportunities in the Pharmaceutical and Biotechnology Industries in Munster, please feel free to send your cv to rory.walsh@cpl.ie .
I will look forward to hearing from you.