Quality Assurance Specialist

Contract
Leinster
Posted 1 year ago

Responsibilities

 

  • Responsible for ensuring that the manufacturing processes for vaccines and biologics follow cGMP and associated regulatory requirements.
  • Responsible for reviewing and approving documentation to support corporate compliance / regulatory expectations for manufacturing and supporting the site Quality Assurance function in ensuring that an effective internal and external auditing program is in place.
  • Responsible for the effective management and stewardship of assigned Quality Systems.
  • Responsible for ensuring that objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and reliable supply to our customers.
  • 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.
  • Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency
  • Actively participate in Plant/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
  • Responsible for supporting quality related customer complaint investigations and trending activities.
  • Aid the effective implementation of the QMS, and facilitate the continuous improvement of same ensuring the QMS are accurate and complete; review on a continuous basis.
  • Advocacy of continuous improvement in QMS.
  • Carry out annual product reviews.
  • Ability to make rapid and informed Quality decisions.
  • Conduct self-inspections and external audits as appropriate.
  • Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
  • Review of site documentation for regulatory impact (e.g. Product Specification Files, QC documents, EBR updates, Quality Notifications, Stability protocols and reports, Validation protocols and reports, process description).
  • Periodic auditing of CMC portion of filings against site systems to ensure continued filing compliance.
  • (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Management of Change Controls (Including Global changes, ORB prioritization, VCMT, PSQTS, etc.) and Tracking regulatory approvals for category 3 changes – market restrictions and associated ORION reports to support batch release.
  • Management of queries from CMC, Health authorities, downstream sites including final releasing QPs relating to registered products and products for registration.
  • Drive effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
  • Ensure reliability and performance by facilitating effective systems for identification of root cause failures, recommendations and implementation of improvement changes throughout processes, ensuring calibrations of equipment are performed as necessary.

 

 

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryQA Specialist

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