QA Support Specialist

Recruiter
Grifols
Location
Dublin, Dublin West
Salary
health insurance ,pension, 25 days hols
Posted
14 Apr 2021
Closes
28 Apr 2021
Ref
QA Support Spec
Contact
Ann Marie Corcoran
Sector
Manufacturing
Job Type
Permanent
Hours
Full-time

QA Packaging Support Specialist

 

The QA Packaging Support Specialist, reporting to the QA Packaging Manager, responsible for ensuring that all activities related to the investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements

Strong knowledge and understanding of regulations and guidelines in packaging processes and QA inspection activities in packaging

Strong knowledge and understanding of Data Integrity requirements

Strong Technical writing skills, problem solving, and analytical thinking are essential to the role

 

RESPONSIBILITIES

Communication:

  • To provide daily report on QA performance information as required
  • To communicate quality metrics information where applicable
  • To attend packaging tier meetings and provide information on investigations progress as assigned by the QA Packaging Manager
  • Ensure regular Quality interaction with other Departments

 

 

Main activities:

  • Proficiently lead and participate directly in the investigation of Deviations/Non-Conformances/Technical Complaints to ensure investigations are completed in a timely manner and high-quality standards
  • Effectively and efficiently write Deviations/Non-Conformances investigation reports
  • Responsible for reviews and evaluations for completeness and compliance of the investigation reports and CAPA plans authored by Subject Matter Experts (SMEs) and other company personnel
  • Responsible for delivering training related to CAPA, Root cause analysis and quality investigations to company employees
  • Efficiently follow up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness in the QA Packaging Department
  • Participate/Lead investigations due to quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
  • To participate/lead Quality risk assessment
  • Responsible for developing SOP's as needed
  • Responsible for periodic reviews and updates of QA Packaging SOPs
  • Participate and action change controls tasks assigned to the QA Packaging Department
  • Responsible for participating in the internal audit program
  • Lead Process/product/system improvement projects in the QA Packaging
  • Training of new QA Packaging personnel
  • GMP implementation and site-wide Quality Awareness related to Packaging process
  • Participate in various inspections g. HPRA, FDA, customers, etc.
  • Liaise with other Department representatives to promote improvements in GMP and Quality standards
  • Any additional tasks as assigned by the QA Packaging Manager

 

REQUIREMENTS

 

  • At least 5 years of extensive experience in a quality or manufacturing setting or similar role
  • Sc. or equivalent in chemistry, biochemistry, pharmaceutical science, or related field
  • Strong Technical Writing skills
  • Competence in Microsoft packages specifically Word, Excel and PowerPoint
  • SAP knowledge
  • Ability to handle multiple projects/tasks and deadlines
  • Proficiency in communicating and collaborating at all levels of the organisation
  • Demonstrated problem solving skills and analytical approach
  • Demonstrated project management skills
  • Strong Decision-Making skills
  • Problem solving techniques.
  • Sc qualification an advantage
  • Knowledge of Quality Risk Management tools an advantage

 

 

 

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