[OFER-TRABEC] NAC: Puesto de trabajo

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---Procedencia:
Institución:Pharma-Bio Serv S.L.
Contacto correo-e:DDunkle@pharmabioserv.com
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We are looking for a pharmaceutical professional with solid compliance background and leadership skills. FDA knowledge is desirable, with +2 years' experience.
This is a permanent position available in the northeastern part of Spain, to create and develop a quality culture with in a plant. The Team player will be serving QA direction input and reviews for all activities related to cGMP compliance and regulatory areas. This is for a project that will pass and maintain FDA readiness and inspections in Spain.
ORGANISATION INTERFACES:
The candidate will interact with all cGMP related departments within a pharmaceutical manufacturing operations leading up to FDA certification and maintaining this culture.

MAIN DUTIES & RESPONSIBILITIES:

PRINCIPLE ACCOUNTABILITIES:
• Participate in the design of quality systems
• Develop and cultivate a quality culture within all departments and the workforce
• Ensure remediation project tasks and milestone tracking and completion
• Provide Quality Assurance compliance drive, guidance and expertise during the deployment of new programs
• Identify and guide training needs
• Develop, train personnel and maintain new habits
• Create policies and procedures
• Create other QA related documents
• Follow up on actions and report project status to management
• Participate in external and internal audits

KEY COMPETENCIES REQUIRED:
• Practical and Customer oriented mindset
• Great People skills
• Excellent communication skills – both verbal and written both in Spanish and English
• Strong collaboration and influencing skills – Both Internally and Externally
• Team building and development capabilities
• Negotiation skills
• Have handled CAPA scenarios, deviations and lab investigations
• Team builder
• Qualification/Validation knowledge

QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
• Pharmacist, Chemist, Biologist, Chemical engineer, or related field.
• 2+ years QA experience – Pharmaceutical Products
• Strong Compliance background
• Team Leader, managerial skills
• Project management skills
• Self-motivated and pro-active to help the QA team
• People oriented to involve aging workforce in the Quality Culture
• Flexible


DESIRABLE:
Experience working within a FDA regulated company
Project management certification or training
Masters' degree in the Pharmaceutical Industry and/or MBA


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Información complementaria de la oferta:
Apoyo integral por parte de Pharma-BioServ S.L.
Puesto con proyeccion y de propuesta de continuidad en el cliente final.
Puesto en la zona nor oeste de España.
Interesadas/os envien C.V. actualizado en Ingles y Español a DDunkle@pharmabioserv.com

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