See All Jobs

Engineering & Technical

Job Description

QA SNR ASSOCIATE with at least 4 years Inspection experience required by CareerWise Recruitment for our BioTech client in South County Dublin, initial 9 month contract on offer. The QA SNR ASSOCIATE will be responsible for sampling and testing of incoming raw materials/excipients and components. They will be a core member of the site Quality Assurance team and will report to a QA Senior Manager.

Role of this position

  • Clean room raw material Sampling required in accordance with procedural requirements
  • Proficiency in ANSI sampling of excipients, chemicals, primary and secondary packaging.
  • Inspect Raw Materials and Components in accordance with site procedures
  • Send Samples for Test to QC or Contract Laboratories in accordance with material Specifications
  • Compile, Review/approve incoming batch related documentation and associated documentation in preparation for disposition activities.
  • Write, review and approve Standard Operating Procedures in accordance client Policies.
  • Provide Quality support for triage and investigation of non-conformances (NC's)
  • Responsible for drafting NC's and CAPA's
  • Participates in customer complaint investigations as required.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Maintain the site reserve/retain samples program
  • Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
  • Support continuous improvement and Operational Excellence initiatives

JOB REQUIREMENTS

  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
  • Operational Excellence experience.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@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.

Apply Now

Engineering & Technical

Cork Office

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

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie