Senior Microbiology Team Leader

About Your New Employer

• Global Multinational: Join a leading company in the pharmaceutical industry, known for its commitment to quality and innovation.
• Career Growth: Opportunities for professional development and career progression.
• Inclusive Environment: A diverse and inclusive workplace that values your unique skills and experiences.

About Your New Job

• Coordinate and Supervise: Oversee all microbiological testing in the Microbiology Lab, ensuring timely completion to meet company objectives.
• Review and Approve: Batch release documentation, raw material, and stability data in compliance with regulatory requirements.
• Leadership and Development: Provide leadership, coaching, and technical expertise to the Microbiology team, setting goals and promoting professional development.
• Manage Investigations: Oversee laboratory investigations, deviations, change controls, SOP updates, and trend reports within the Microbiology Department.
• Ensure Compliance: Maintain high quality standards and adopt industry best practices in compliance with current GMP, GLP, and regulatory directives.
• Instrument Management: Schedule and manage calibration and maintenance of laboratory instruments and equipment.
• Method Validation: Ensure test method validity is established, documented, and maintained in the Microbiology Lab.
• Deputy Role: Act as Deputy/Designee for the Microbiology Lab Manager, supporting departmental oversight and decision-making.
• Environmental Monitoring: Manage the environmental monitoring program, investigate out-of-specification results, and implement corrective actions to maintain aseptic manufacturing conditions.
• Aseptic Process Simulations: Oversee aseptic process simulations (media fills), including scheduling, report review, and approval.
• Contamination Control: Support the development and execution of a comprehensive contamination control strategy, track relevant quality system metrics, and represent the department during audits and regulatory inspections.

What Skills You Need

• Educational Background: Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. A combination of experience and/or education will be taken into consideration.
• Regulatory Knowledge: Knowledge of Annex I and US and EMA GMP regulations.
• Technical Expertise: Working knowledge of isolator technology and MODA.
• Industry Experience: Experience with sterile injectable products, aseptic manufacturing processes, and contamination control strategies.
• Leadership Skills: Excellent leadership, communication, and problem-solving skills.
• Cross-Functional Collaboration: Ability to work cross-functionally with other departments (Analytical, Quality, Manufacturing, and Regulatory).
• Technical Proficiency: Proficient computer skills (Excel, Word, PowerPoint, databases, Microsoft project planning or similar software).
• Organizational Skills: Excellent planning and organizational skills, ability to work in a fast-paced environment, adjust quickly to changing priorities, and handle multiple tasks simultaneously.

What’s on Offer

• Career Progression: Excellent career progression opportunities.
• Work-Life Balance: Initiatives to support work-life balance.
• Bonus Scheme: Competitive bonus scheme.
• Health Insurance: Comprehensive health insurance.
• Pension: Attractive pension plan.

Apply now by clicking the “Apply Now" button or call me, Karolina, on 091749267. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.