Quality Compliance Specialist

1 day left

Recruiter
Grifols
Location
Dublin West, Dublin
Salary
bonus, pension health insurance
Posted
12 Jan 2023
Closes
09 Feb 2023
Ref
Q&C Specialist
Contact
Ann Marie Corcoran
Sector
Scientific
Job Type
Permanent
Hours
Full-time

Quality Compliance Specialist

Reporting to the Quality Compliance Assistant Manager, the Quality Compliance Specialist is responsible for maintaining site compliance of Operations inclusive of, but not limited to, Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Materials handling, and Validation in accordance with regulatory requirements and site expectations.

Responsibilities include participating as an SME in self-inspection, Health Authority (HA), Corporate or Customer inspections. Collaborating with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Support the site Quality Council program. Support the GMP/GDP training program. Participate in the global working groups to ensure best practices are implemented on site. Support the requirements of master data set up in the SAP system.

Contribution to the continuous improvement of the Quality Management System is required. Due to the nature of the business additional duties may be assigned from time to time.

Experience working in aseptic area and understanding of Annex 1 requirements will be considered an advantage. Experience with SAP-QM will be considered an advantage.

 

What your responsibilities will be

  • Participating as an SME in self-inspection, Health Authority, Corporate or Customer inspections.
  • Support audit readiness activities and act as a key member of the audit support team during inspections.
  • Collaborate with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  • Support the evaluation the regulations and industry trends to identify opportunities and to strengthen the GxP training program
  • Support the site Quality Council program.
  • Participate in the global working groups to ensure best practices are implemented on site.
  • Provide Reports to site in relation to Quality Management System (QMS) as required.
  • Provide regular reports on site metrics to Quality Compliance Assistant Manager
  • Support the authoring of Standard Operating Procedures (SOP's) in relation to the Documentation System
  • Review of procedures, policies and other instructional documents relating to quality management system to ensure compliance to company policy and local and international regulatory requirements. Identify gaps in systems and develop feasible plans for correction.
  • Communicate with cross functional departments sites on compliance issues and organise retraining where require
  • Actively participate in continuous improvement initiatives.
  • Participate in quality risk assessments.
  • Ensure systems to measure, assess risk and escalate quality issues.
  • Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
  • Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated.
  • Support quality events to identify, bracket, correct, control, and prevent defects.
  • Participate in quality management system improvement initiatives.
  • Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
  • All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

 

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Minimum of 3 years' experience in Quality Systems/Quality Assurance environment.
  • Excellent understanding of GMP regulations and guidelines.
  • Highly motivated with an ability to multitask, prioritise workload and work in a self-directed manner.
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong ability to problem-solve and identify areas for continuous improvement.
  • Previous involvement in HA audits and audits' follow up actions.
  • BSc or MSc in a science, pharmacy or related discipline.
  • Ability to handle multiple projects and priorities with exceptional organisational time management skills.
  • Excellent communication skills, both verbal and written
  • Competence in Microsoft packages specifically Word, Excel and PowerPoint
  • Detail oriented with ability to work in teams and proactively on own initiative
  • Excellent technical writing and analytical skills
  • Results orientated
  • Process improvement and procedure writing expertise
  • Experience in audit/inspections
  • Flexible, able to adapt quickly to change in a fast-paced environment
  • Solid problem-solving skills
  • Ability to use data to drive results, desirable
  • Understanding of the functionality of SAP-QM for result recording and batch release, desirable

 

  • Benefits package
  • Hybrid Working
  • Contract of Employment: Permanent position

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