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Scientific & Laboratory

Job Description

A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Carlow-based multinational bio-pharmaceutical client. The QA Specialist role supports the introduction and execution of new products, materials and drug substance into the client facility. The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
  • Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements
  • Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing
  • QA oversight on the receipt and release of Drug Substance to site

Role of this position

  • Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy
  • Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings
  • Participate as functional expert in the cross functional team that manages introduction of products and materials at the client facility
  • Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities
  • Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation
  • Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc)
  • Provide quality oversight and direction for Material introduction process and external party management
  • Development and monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested
  • Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used at the client facility are correctly set up
  • Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions
  • Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives

JOB REQUIREMENTS

  • Bachelor Degree or higher preferred: ideally in a related Science discipline
  • 3-5 years' experience in a quality role, ideally in a pharmaceutical manufacturing environments
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Knowledge of cGMP and GDP preferred
  • Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job related computer applications required
  • Lean Six Sigma Methodology experience desired
  • Good Collaboration Skills
  • Ability to work as part of a team to determine priorities
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Demonstrated ability to drive the completion of tasks
  • Proven decision making capability with accountability and responsibility
  • Demonstrated ability to solve problems

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie