Quality Management Lead

1 month ago

Northern Ireland, United Kingdom Team Horizon Full time

Team Horizon is seeking a Microbiology Lead for our client based in Mayo.

Responsible for the supervision of the Microbiology Department and a team of microbiologists.

* 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.

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