sterility assurance lead.

Responsibilities:
● 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 on the floor, within the team, the management of the quality events with an impact on sterility, supporting the evaluations on deviations and complaints with microbiology impact.
● Owns and maintains the site microbiology risk assessment and Sterilization-in-place concept.
● 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 (EU GMP 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 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

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.