Requirements: English
Company: Winid Spain
Region: Barcelona , Catalonia
Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.
About the client:
We are seeking a Corporate External Quality Assurance Specialist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model.
Your Mission
The Corporate External QA Specialist is responsible for maintaining and improving an effective and efficient quality assurance system that ensures the compliance with current regulations (including but not limited to: GMP, GDP and ICH Quality guidelines) to guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested and distributed in accordance with the quality standards appropriate to their intended use and as required by the Marketing Authorization, which ensures the quality, efficacy and security of the medicinal products for patients.
Become the expert regarding the quality along the lifecycle management of the assigned molecules and FDFs, which includes changes in manufacturing and testing, resolving quality incidents, addition of new sources of API and any change that could affect to the manufacturing process related with externals CMOs.
Your Major Accountabilities
- Supervise the quality of the product and drive continuous improvement.
- Support the assigned Product Lifecycle projects.
- Supervise activities of the CMOs.
- Supplier qualification management.
- Execute internal and external audits. Attend audits from Health Authorities and customers.
- Write, review and approve technical documents: SOPs, master batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, Quality Agreements, environmental conditions, etc.
- Write, review, approve and monitor CAPAs, deviations, OOS, complaints and change controls.
- Write, review and approve Product Quality Review reports.
- Prepare and execute GMP training.
- Compliance (internal procedures vs filed documentation).
- Write, execute or review qualifications (equipment, utilities and facilities) and validations (e.g. process, cleaning).
- Perform Compliance checks (internal procedures vs filed documentation).
- Execute internal and external audits. Attend audits from Health Authorities and customers.
- Prepare and execute GMP training
- Attend requests regarding quality related to marketed products.
- Participate in the several corporate assigned projects.
We Would Like You To Have
- University Degree in Life Sciences or Engineering
- Minimum experience of 2 years in a Quality Assurance Department in a Pharmaceutical company or similar
- Key Capabilities: Analytical mindset, Communication, Problem Solving and Quality Orientation.
- Expert in GMP and Quality Management System
- Expert user of MS Office, SAP & LIMS
- Availability to travel to conduct audits
- Open mentality to new projects and changes, and commitment with the continuous improvement and promotion of the quality standards established in the company
- Proficiency in English
What we offer:
- Individual Professional development in a leading pharmaceutical company with an ambitious international growth strategy.
- Attractive remuneration according to the experience and skills provided.
- Flexible working hours
- Private health insurance for all employees
- An inspiring leadership team that drives performance.
- An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert & excellent team!
- Hybrid role