Senior QA Sterility SME

Work Schedule

Environmental Conditions

Job Description

Job summary:

This position is expected to be the QA – Sterility Assurance Lead (Senior QA Sterility SME) for the entire site. Oversees, runs, and ensures the successful day-to-day operations.

Responsibilities:

• Ensure the safety message that the first goal of all employees is safety is implemented and lived throughout their organization as possible.
• Own and drive the Contamination Control Strategy and Sterility Assurance strategy for the site in compliance to the most updated regulations, using good practices and continuous changes.
• Assure the surveillance plan of operational activities to be carried out in respect to the current procedures, giving support so that such interventions are performed to reduce the environmental contamination and the product risk to a minimum.
• Collaborate within the team, the management of the quality events with an impact on sterility, supporting the evaluations on deviations and complaints with microbiology impact.
• Responsible for writing and/or review of SOPs related to sterility assurance. Actively participate in the evaluation of changes which may have impact on the quality of the products.
• Support the EM review/evaluation including the relevant action plan requested in the light of the site continuous improvement plan, in collaboration with other company structures, an improvement of the processes and systems to increase the Sterility Assurance Level.

Requirements:

• Master Degree in Microbiology.
• At least 5 proven years experience in microbiology in pharmaceutical industry.
• Practical knowledge in GMPs and Regulatory Compliance, especially for sterility assurance (annex 1).
• Extensive background on sterility assurance, process and cleaning validation concepts and contamination control strategy. Applies GMP regulations and other international guidelines to all aspects of the position.
• Strong interpersonal and communications skills; Ability to make scientific decisions. Able to build and maintain highly functioning teams, cohesive, targeting for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
• Participates and/or leads meetings, to provide input on timelines, potential compliance issues and other related QA activities.
• On-call services, remote, based on department organization.
• Fluency in English, German is a plus.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status!