Senior Specialist - Quality - 12 month contract
Chiajna, Romania
1 zi în urmă

The Role :

Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our company is hiring a Product Quality Manager on a 12-month, fixed term contract basis. This role will sit within the External Quality Assurance, Sterile Team and be responsible for providing quality support to our European CMO supplier.

Location for this role can be based in our company in Ireland or flexible across our company Europe.

Roles and Responsibilities

  • Perform EQA releasing of sterile products, manufactured at Contract Manufacturing Organisations (CMO) to downstream site with the assurance that the goods were manufactured in conformance with all applicable policies / procedures of our company and in Compliance with all governing Regulations.
  • Responsible for implementing Quality Control policy supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics, by means of a risk based quality oversight, on site quality support and technical advice, counselling of manufacturing site senior leadership and providing routine on-site supervision as appropriate.
  • Provides Quality Control oversight for method validations / method transfers and method improvements at external parties.
  • The incumbent will review the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions and follow up and ensure timely close out of all corrections associated with the Batch Record Review.
  • Participate in routine weekly Tier 2 meetings / teleconferences between ExM Focus Factory and Contract Manufacturing Operations (CMOs).
  • Co-ordinate the full investigation into all Customer Complaints received for any of the batches manufactured by the CMO s.
  • Assures CMO compliance with established policies / procedures of the Division and Corporate and complies with all applicable governmental Regulations (GMP, FDA, ANVISA, etc.)
  • Responsible for on-going execution of the Quality Agreement with the External Party.
  • Contribute to EQA Management Operational and Strategic Initiatives.
  • Promote and participate in the implementation and maintenance of the SHE / EHS Programmes relevant to you.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA's assigned to you.
  • Provide Quality Oversight to the preparation of the Annual Product Review Report for the products associated with the CMO.
  • Tracks and monitors Quality performance / KPIs of the external manufacturer.
  • Assists in the co-ordination of significant investigations including Fact Findings. Assist in the co-ordination of any product recall involving the external manufacturer.
  • Qualifications and Experience

  • Degree or 3rd level qualification (Chemistry, Microbiology, Production, Mechanical, Process, Industrial, or Electrical or equivalent)
  • Evidence of Continuous Professional Development.
  • Knowledge in more than one pharmaceutical and / or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc) is desirable.
  • Knowledge and experience in dealing with Quality related issues associated with third party Contract Manufacturing of Vaccine / Aseptic products (Vial, Syringes or Cartridges) is desirable.
  • Experience in the Pharmaceutical industry or a similar operating environment with experience in either a Quality, Technical or Operational role in a manufacturing environment.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, along with an understanding of regulatory and validation requirements.
  • Demonstrated leadership skills with a continuous improvement focus.
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