- Electronic Data Management System support:Assist with maintenance of the Document Management System. Responsible for drafting and reviewing SOP's, Forms, and Specifications required to support GxP requirements.Implement compliance related CAPAs and Change ControlsAssist with integration of new business lines into the QMS.Investigate deviations and write the deviation report for compliance related deviations.
- Data Generation and Evaluation:Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Monthly Metrics, Management Reviews). Host quarterly KPI meetings, as needed.
- Project SupportSupport global procedure harmonization activities.Support additional projects as identified by manager.
- Quality System Support:Support Supplier Management with supplier qualification activities and maintenance of Approved Supplier List(s)Lead or participate in internal /supplier audits.Assist with preparation and execution of backroom activities for Regulatory/ Notified Body Inspections conducted at the Dublin site and other sites as needed.
- Liaise with the corporate and site quality functions as required for information and project support.
- Support maintenance of Licenses including Manufacturing license and Wholesale Distribution Authorization, ISO 13485 Certification
- Training SupportConduct new hire Induction GMP trainingConduct annual GMP Training
- Bachelor's Degree in scientific discipline preferred plus 3-5 years' experience working as a QA Specialist or Quality System Specialist
- Direct experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
- Advantageous qualifications:Master Control experienceAuditor certification or experienceKnowledge of Data Integrity and computerized systemsKnowledge of cGXP requirements for pharmaceutical manufacturing and medical devicesPrevious experience in a pharmaceutical manufacturing plant
- Represent Mallinckrodt interests, objectives and policies in a professional and responsible manner.
- Excellent problem solving skills.
- Demonstrate an ability to work independently.
- Strong organizational skills.
- Accountable for completing activities within required timelines.
- Able to function effectively in a teamwork environment.
- Demonstrate good interpersonal and communication skills (verbal and written).
- Thorough, diligent, and excellent attention to detail.
- Collaborator with strong levels of engagement with individuals and team.
- Proactively highlight any issues around compliance.
- Willingly accepts challenging assignments.
- Strong Microsoft Office skills (Word, Excel, PowerPoint etc.)
- Travel requirement up to 10% to support audits / compliance activities at other locations
QA Compliance Specialist - Dublin, Ireland - Mallinckrodt Pharmaceuticals
Description
Description
SUMMARY OF POSITION :
The QA Compliance Specialist is responsible for supporting the Quality System functions as it relates to QA Compliance as well as projects associated with the following systems: Document Management, Training, Change Control, Deviations, CAPA, Internal and Supplier Audits. The role will also support maintenance of licenses, regulatory audit support activities and integration of newly acquired products into the existing global Quality System.
The role reports to the Senior Manager, Global QA Compliance located in the US.
BACKGROUND AND CONTEXT:
The role will be based in the Dublin Corporate office of Mallinckrodt and will support the Specialty Brands QMS covering commercial and pre-commercial products for pharmaceutical, biopharmaceutical, medical device and combination products.
Essential Functions:
Roles and Responsibilities:
Qualifications and Education Requirements:
Competencies/Preferred Skills;
#LI-KD1