Pharmaceutical products

Pharma-Bio Serv S.L.

Alcobendas, Spain

 

Description

 

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. The candidate will interact with all cGMP related departments within a pharmaceutical manufacturing operations leading up to FDA certification and maintaining this culture. Responsibilities:

 

• 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

 

Requirements

 

• 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

 

Applications

 

Please send your C.V. (English & Spanish) to DDunkle@pharmabioserv.com