Job Description
This QA Specialist position will report directly to the Site Quality Systems and Standards (QSS) Lead and together with the QSS Leader will serve as partners alongside other stakeholders to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready.
The QA Specialist will have responsibility for supplier evaluation, approval and supplier management.
Key objectives of this position include:
Evaluation, Approval & Monitoring of vendors including Quality Agreements (End to End Supplier Approval and Management)
Provide QA support to Operations in terms of ensuring that GMP activities follow regulatory, corporate and site procedures.
Provide QA support for Deviations, CAPA’s, change control, Cleaning Validation and Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
Review /Approve Master Batch Record (MBR), Review Batch Records / Review Cleaning Records as per the site procedures.
Perform/Lead Internal Audits/Quality Walkthroughs
Quality Oversight of Warehouse and GMP Service Providers
Manage Vendor audits from planning to close out.
Support Internal Inspection Readiness, Corporate and Regulatory Inspections.
Management of Regulatory Changes
Support continuous improvement initiatives, ensuring quality is built in and all corporate and regulatory requirements are met
Serving as a quality culture role model and instill a strong quality and compliance culture across the site.
Assure the use of operational excellence tools in quality procedures and processes,
Support the development of quality goals and targets as part of the organisation’s strategic plan,
Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology,
Active participation in site Tier meetings
Comply with the relevant Safety Statutory provisions and must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.
Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.
Ensuring that they perform their role to a high standard and deliver on objectives/duties assigned to them.
EDUCATION AND EXPERIENCE
Undergraduate degree in pharmaceutical, biological or chemical sciences
Relevant advanced degree preferred
3 to 5 years relevant experience in the Pharmaceutical with a current knowledge of cGMP’s and regulatory guidance required.
Significant experience in QA supplier management and ISO 9001 and or Regulatory Affairs is desirable.
Success in developing, implementing and maintaining Quality Systems and Standards at the manufacturing site level in accordance with ICHQ10 key principles
ICHQ7 Manufacturing Site experience preferred
Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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