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Quality Assurance Manager Iberia , Barcelona

Created 02/03/2021
Reference 68725044
Category Inspectors, Testers, Sorters, Samplers, and Weighers
Job type Full Time
Country Spain
City Barcelona
Zip Not specified
Salary Competitive
This position will report to Head of Global Quality Assurance in EU+ with the remit and objective to ensure the integrity of LEO products. The QA Manager ensures that the manufacturing and distribution of LEO products are done according to regulations. This function maintains quality compliance with Good Manufacturing Practices (GMP), Good Distribution Practice (GDP) and LEO Standard Operating Procedures (SOPs). The quality function also ensures the timely release of incoming product batches into the marketplace for sale; assisting LEO Pharma in meeting financial sales targets and ensuring that quality product is available to patients.

This position include fostering and nurturing strong stakeholder relationships with many functional areas across LEO Pharma, globally and locally and with competent authorities.

As our Quality Manager for LEO PHARMA Iberia you will become part of Development & Global Support Quality, a global quality organization with local presence. We have intensified our focus on developing our local quality functions and strive to deliver best-in-class quality partnering to internal and external stakeholders. To do so we need to be in close dialog with our colleagues at the affiliates to gain knowledge about development activities, product introductions/strategy and business insights. Besides being a quality sparring partner we are also the link between Global Quality and local Quality functions ensuring that projects, audits and quality oversight run seamlessly.

Your main tasks will include

- Development and maintenance of appropriate local Quality Management System to ensure that the operations are in compliance, driving continual improvement. KPI reporting.

- Acting as Deputy pharmacist responsible person for LEO ES (QP) and being the deputy responsible person on the license of LEO Pharma ES. Lead and management of pharmacist responsible person for LEO PT.

- Ensure that the organization understands and complies with internal and external regulatory framework and compliance standards.

- Local batch release management: Timely approval of incoming batches, batch inspection and perform release according to LEO SOPs

- Maintenance of quality agreements with manufacturers, 3PLs, wholesalers and distributors, when applicable

- QA document management, archiving of QA documents for inspection readiness.

- Vendor management of QA in PT.

- Local contact responsible person for serialization (SEVEM in ES) and packaging waste (SIGRE in ES) and support to PT activities regarding serialization (NVOPT in PT) and packaging waste (VALORMED in PT).

- Manage and evaluate (trending) product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs)

- Stop the distribution of products if a serious/critical deviation happens.

- Annual product reviews and review of stability reports for compliance with Spanish registration.

- Lead/collaborate with Iberia organization on change controls.

- Responsible for updating/maintaining local Quality SOPs and training matrix.

- Monitor of global SOPs updates and assess local impact. Preparation and development of local SOPs.

- Support inspections to distributors and wholesalers as necessary as per GDP/GMP requirements.

- Act as primary quality contact person with Third Party Logistics (3PL) and as qualified person for internal quality compliance matters

- Monitor QA aspects of warehousing and shipping practices for compliance with GDP

- Implement recall procedures if necessary and perform mock recall to ensure our recall procedures are adequate. Take decision of recall of a product if there is a serious/critical deviation.

- Manage returns: approve any returns to saleable stock.

- Decide on the final disposition of returned, rejected, recalled or falsified products.

- Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.

- Assist Regulatory projects that involve QA oversight including stability changes, updates to labelling etc.

- Support the Market Product Review

- Out of stock notifications to competent authorities

Requirements

  • Degree in Life Sciences, B.SC. in Pharmacy or equivalent experience
  • Fluent English, written and spoken.
  • 5+ years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs
  • Experience with Spanish Medicines Agency GDP/GMP inspections and third party audits.
  • Solid decision making skills and computer skills
  • You are energetic, result oriented and you thrive in the role of counsellor and have a strong "customer focus".
  • Working cross-organizational takes strong communication and collaboration skills in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.
  • Ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.
  • Personally you are trustworthy and reliable as you will be interacting with senior levels of the business.