Business Development Manager - Portuguese Market, Valencia

Quality Assurance Manager & Qualified Person

Location: Alicante

Our client is a multinational pharmaceutical company, with an important subsidiary in Spain. The company has several manufacturing plants that serve international markets, one of them located in Spain. Reporting to the Global Quality Manager, and with a team of 2 Specialists, the Quality Assurance Manager & Qualified Person will be responsible for:

Local Quality Assurance:

• Maintenance and continuous development of the quality system and local implementation of the global Quality Management System as well as control of compliance with GMP / GDP / GVP guidelines.
• Contact person for local organization and the Global Quality structure for quality matters and for internal and external inspections / audits.
• Creation, adaptation and rollout of quality agreements, SOPs and work instructions (GMP / GDP / GVP).
• Training System management covering quality GMP / GDP / GVP matters.
• Change, Product and Service Quality Complaints, Deviation and CAPA management.
• Local GDP Regulatory intelligence and quality alert monitoring.
• Key performance indicators (KPIs) follow-up and collection of quality-related data for processes at local level.
• Qualification and oversight of local suppliers and local customers.
• Self-inspection and audit to Local Supplier.
• Supplier quality monitoring and issues management.
• Product Quality Review management.
• Readiness management in case of Local HA / Partners / Global Quality inspected / audited.
• Local Quality Management review.

Responsible Technician:

Product release on the market.

• Quality issues management regarding and impacting internal warehouse processes and supply.
• Deciding on the final disposition of returned, rejected, recalled or falsified products.
• Approving any returns to saleable stock.
• Evaluation of customer complaints and non-conformities.
• Coordinating and promptly performing any recall operations for marketed products.
• Serialization alert management.
• Quality related contact to local authorities.
• Supervise Risk Assessment.
• Host inspections performed by Local HA / Partners / Global Quality when the company in Spain is inspected / audited.

Required Profile:

• University Education (Pharmacy Degree)
• 3 years of experience in the pharmaceutical area (good knowledge of GMP / GDP)
• Previous experience in Responsible Person or RP deputy role is a plus
• Project management skills.
• Knowledge of e-QMS (Trackwise) and e-DMS (Documentum) is an advantage
• Good written and spoken Spanish and English skills
• Very good Microsoft Office, especially Excel knowledge
• Systematic, independent working method, accuracy, reliability as well as ability to work in a team