QA Compliance Executive応募 後で応募 求人ID R0012424 掲載日 10/01/2019 Location:Wicklow, Ireland
This brief demands a thorough knowledge and understanding of pharmaceutical solid dosage validation procedures with technical understanding of process equipment and unit processes used therein.
• Execution of site validation activities including:
Qualification of equipment
Computer system qualification
Qualification of utilities and facilities
• Maintaining/Improving the validation system within the company
• To assist the Compliance Specialist in the implementation and active participation in TIL Validation Procedures across the TIL plant.
• To review and evaluate FAT/FMEA/FS/URS/SDS/HDS/MR documents and report to ensure a good design basis is established for all validation studies
• To assist and advise the validation of new/existing processes and equipment and liaise with production/scheduling departments on validation issues
• To report and update the Compliance Specialist in Validation Activities across the plant as and when required.
• Preparation, review and execution of validation plans, CR/RA/DQ/IQ/OQ/PQ/PV/CQ protocols/reports and associated deviations/NCRs for equipment, facility, utility, process, cleaning & computerised systems.
• Statistical review of validation data.
• Liaise with vendors, external consultants & TIL departments on validation issues
• Assist in the maintenance of TIL production, engineering and quality systems and to ensure that the Validation projects/activities are executed in a timely manner and in compliance with the overall TIL Quality Management System.
• Ensuring compliance with current industry regulations and guidelines relating to validation
• Participate in cross-functional training, and direct training of validation designees by maintaining and improving validation SOPs, forms and training manual.
• Participation in maintaining Validation KPIs
• 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 Manager, Compliance or other Officer appointed by the Board of Directors.
• Third level qualification in a Science, Engineering or IT discipline.
• Good knowledge of Pharmaceutical Production & Packaging processes.
• At least 3 years experience working in a validation role in a regulated environment
• Excellent interpersonal and communication skills
• Strong planning and organization skills
• People management experience would be an advantage
• Solid Oral Dosage processing experience is highly desirable
• Good knowledge of GMP, validation regulations and guidelines is highly desirable
• A strong technical understanding of processes, equipment and computer systems is advantageous
• Experience in data integrity practices would be an advantage
• Experience/ Interest in IT/software systems is a benefit.
• Experience/ Interest in analytical validation is a benefit.
• Strong documentation skills & attention to detail.
• Be a self starter who is willing to learn.
• Strong Interpersonal & communication skills.
• Problem solving capability.
• Good organisational skills.