About the Role
The SCO Bioprocess Specialist & Permanent Inspection Readiness Lead is responsible for providing technical leadership and leading permanent inspection readiness within SCO. This role requires a high level of initiative, influencing, and questioning skills, as well as excellent organisational skills.
Main Responsibilities:
• Compliance Leadership: Investigate, write, and approve investigations and CAPA implementation on site QMS system
• Team Leadership: Foster a safety and quality-focused environment through inspection readiness coaching support
• Partner with validation subject matter experts to prepare and approve validation protocols, plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts
• Develop and maintain an internal compliance programme within SCO
Requirements:
• At least 3 years of experience in a regulated manufacturing environment with excellent knowledge of quality systems
• Strong communication and interpersonal skills - oral, written, and formal presentation skills
• Creative problem-solving skills
• Bachelor's degree in biotechnology, chemical or biochemical engineering, biochemistry, or bio-systems engineering, or related field, or equivalent experience in a GMP environment