Supplier/Vendor Qualification Technician

GenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.

GenIbet is looking for a Supplier/Vendor Qualification Technician to join our Quality Systems team.

Mission:

The Supplier/Vendor Qualification Technician is responsible for driving Supplier and services management to ensure that they comply with the required quality standards (GMP, International, National, and internal company regulations).

Your key responsibilities:

· Qualification of Suppliers of: Materials (RM,PKs, DI), Services, Third Party Manufacturers and Contracted Analysis Laboratories

· Generation, revision and updating of documentation related to external audits and supplier qualification processes: Technical Agreements, Pre-audit Questionnaires, Audit Reports, etc

· Generation, implementation, and follow-up of the Internal Audit plan

· Follow-up of CAPAs generated in the process of Internal, External and Regulatory Entities Audits

· Handling of Supplier Complaints

· Back-up of Incidents and Deviations, Change Controls and CAPAs. Evaluation and follow-up of Change Controls related to Suppliers and Audits

· Implementation, reporting and monitoring of KPIs

· Generation and review of SOPs. Implementation and monitoring of SOPs related to supplier qualification, internal walk-throughs (self-inspections) and supplier claims

· Ensure quality assurance organization and operating procedures are in place to support assigned programs of work

Profile

· Academic education in pharmaceutical fields of study

· More than 2 years of professional experience in supplier and services management or Quality Assurance in pharmaceutical sector

· Fluent English (spoken and written)

Skills and attributes for success

· Business mindset

· A strong work ethic

· Systematic knowledge and study of the most recent Global, Regional and local risk management policies and procedures

· Technical rigor and attention to detail

· Strong problem-solving skills

· Professional responsibility, confidentiality and integrity

· Efficient, innovative and team-oriented work environment

· Dedicated, innovative, resourceful and able to work under pressure

· Ability to manage multiple projects and stakeholders

If you want to join us and be part of a unique Team that works on a daily basis to make a positive difference in people life´s, send your application.