business development executive jobs

Near cavan
2Jobs Found

2 jobs found for business development executive jobs Near cavan

T
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Quality Systems Executive

Takeda Pharmaceutical

Ireland
2 days ago
Ireland
2 days ago

Job Description

  • Supervisory duties for Quality Systems personnel within the Quality Systems group.
  • Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, change control, deviations, CAPAS, documentation, supplier quality management and GMP training.
  • Provide oversight and management of the supplier approval programme and the external audit schedule.
  • Participate in the internal audit schedule.
  • Administration/co-ordination of risk assessments.
  • Develop and write SOP & Controlled Documents.
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
  • To ensure that the systems with a GMP impact are maintained as per written procedures.
  • Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Quality Management Systems.
  • To be cross-trained in multiple quality systems.
  • Participate in other projects as directed by the Quality Systems & Compliance Manager.
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Bachelor's degree in chemistry, biology or a related scientific discipline.
  • A minimum of 10 years working within quality in the pharmaceutical industry.
  • A minimum of 5 years’ experience in a people management role is desirable.
  • Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
  • Thorough understanding of quality systems and cGMP's.
  • Excellent verbal and written communication skills.
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
  • Work directly with other key departments to ensure compliance and productive working relationships.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
T
T

Analytical Services Executive, Cell Therapy

Takeda Pharmaceutical

Ireland
1 day ago
Ireland
1 day ago

Job Description

  • To develop and maintain required documents, including SOPs, specifications, and forms for all QC computerised systems, in conjunction with QC Manager \ Site Quality Head or designees. To facilitate dialogue\support between the LIMS/Empower vendors and the system users, to troubleshoot and resolve issues.
  • Implement and validate Takeda Grange Castle test methods
  • To execute and review validation and data migration within protocols and reports
  • Responsible for:
  • Computerised System Administration.
  • LIMS Static Data load for all test methods
  • LIMS data management and maintenance
  • Integration of all laboratory equipment and associated software to LIMS where possible.
  • Contribute effectively to the design and implementation of quality systems in the QC laboratories to comply with relevant current regulatory expectations.
  • To identify and support the implementation of functional area end-user requirements and enhancements.
  • To deliver training as appropriate to users and\or the functional area, and to maintain adequate records.
  • To identify report requirements for functional areas, to design\develop or assist in design\development of reports.
  • To provide support to other business systems with respect to the interface with LIMS/Empower, to assist in developing instrument integration and data acquisition.
  • To assist in validation activities (IQ, OQ, PQ) as required, coordinating and\or executing various portions of system validation, for example performance qualification.
  • To ensure the system static data is updated in a timely manner to ensure compliance.
  • Change Control owner related to any activities of new Instrument /Software  Qualification.
  • To work in conjunction with the LIMS/Empower users to ensure compliance across all user groups.
  • To liaise with QC, QA, IT and Manufacturing Operations departments in the performance of normal duties.
  • To carry out the investigation into any non-conformance, accident or other abnormal occurrence
  • Implement and maintain standards of safety to ensure a safe working laboratory.
  • Support major projects, quality initiatives and continuous improvement programmes within the QC department(s) and in other functional areas
  • To highlight and where necessary implement new technologies in QC area.
  • Preparing for and support external audits (HPRA, FDA, corporate, client).
  • Ensure data integrity guidelines are implemented and adhered to for QC based systems.
  • Co-Ordination of all Instrumentation Life Cycle activities.
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Minimum of a BSc Degree (life science).
  • Practical experience working in a GMP laboratory (minimum 3 years).
  • Practical experience working with LIMS and Empower as data input or reviewer (minimum 2 years).
  • Working with Labware LIMS is preferred but not essential.
  • Lab Equipment Management and Qualification desirable.
  • Experience with writing SOP’s / validation protocols.
  • Experience with computerised Laboratory systems.
  • Experienced in technical writing.
  • Good project management.
  • Good time management.
  • Ability to work on own initiative in an unsupervised manner.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
No More Results

Posted

2 days ago

Description

Job Description

  • Supervisory duties for Quality Systems personnel within the Quality Systems group.
  • Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, change control, deviations, CAPAS, documentation, supplier quality management and GMP training.
  • Provide oversight and management of the supplier approval programme and the external audit schedule.
  • Participate in the internal audit schedule.
  • Administration/co-ordination of risk assessments.
  • Develop and write SOP & Controlled Documents.
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
  • To ensure that the systems with a GMP impact are maintained as per written procedures.
  • Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Quality Management Systems.
  • To be cross-trained in multiple quality systems.
  • Participate in other projects as directed by the Quality Systems & Compliance Manager.
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
  • Bachelor's degree in chemistry, biology or a related scientific discipline.
  • A minimum of 10 years working within quality in the pharmaceutical industry.
  • A minimum of 5 years’ experience in a people management role is desirable.
  • Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
  • Thorough understanding of quality systems and cGMP's.
  • Excellent verbal and written communication skills.
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
  • Work directly with other key departments to ensure compliance and productive working relationships.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Source: Takeda Pharmaceutical