Senior Quality Specialist

hace 2 semanas

Madrid, Madrid, España Msd A tiempo completo
Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

The Senior Quality Specialist within External Quality is responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements.

The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies, and guidelines governing the External Partners (EP/ExP's) manufacture and release of Vaccine or Biologic Drug Substances and/or Drug products by means of risk-based quality oversight and on-site supervision, as appropriate.

The Senior Quality Specialist will work within the Focus Factory Team to support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following:

  • number of products manufactured
  • number of partners supported
  • production volumes
  • number and complexity of in-markets
  • historical performance (production and compliance)
  • new product or market launches
  • historical relationship between our company and the partner
  • manufacturing process complexity

Primary Activities may include, but are not limited to the following:

  • Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records.
  • Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.
  • Provide support for audits of EP/ExP by ourselves and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
  • Conduct routine and solve complex analytical change requests and support process modification change controls Stability Program management, including review of stability reports, and Annual Product Review assembly.
  • Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.

Track and monitor operational and quality performance of the external manufacturer/partner and work with suppliers to develop CAPA plans

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