Quality Management Lead H/F - Northern Ireland, United Kingdom - Team Horizon

Description

• Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required.
• Responsible for the generation of documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.
• Responsible for the identification and communication of adverse trends in routine microbiological monitoring
• Oversee sterilization testing and testing to support manufacturing and new product development.
• Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
• Your role will be to maintain regulatory compliance through established programs for lab testing, training, SOPs, and validation.
• Review and approve laboratory testing documentation.
• Assist in the writing of functional area status reports, regulatory documents, and process descriptions.
• Maintain environmental monitoring program.
• Maintain risk assessments required for parametric release.
• Management of lab equipment including, Qualifications, e.g. Participate in all GMP and operational training programs & complete associated Training Records
• Participate in internal and external audits (including regulatory

3rd level Degree in Microbiology or relevant experience in a similar field 5 years or more experience in a regulated pharmaceutical environment including people management experience.

• Experience of environmental monitoring and bacterial endotoxin testing Familiarity and understanding of FDA and EU pharmacopoeial requirements.
• Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects
• Experience in supervising and motivating a team, project management experience and meeting deadlines.