- 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
- 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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Junior Project Officer
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Morgan McKinley Ireland, United KingdomMorgan McKinley is recruiting for a Junior Project Officer on behalf of a leading bank based in Belfast. The Junior Project Officer will be rewarded with a hourly rate of upto £38 on an initial 4 month contrat. · Description: · The role will be to support the Program Manager and ...
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Area Manager
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Ad Ops Lead
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Senior in House Lawyer Corporate/risk
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Ad Ops Director
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Property Manager
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Marketing Executive
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M&e Project Managers Belfast Landmark Project
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Pre-construction Manager
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Director of Digital Services
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Hays Specialist Recruitment Limited Ireland, United KingdomLead on a portfolio of complex IT transformation programmes across health and social care services in NI. · Director of Digital Operations · Remuneration: £competitive, commensurate with experience, plus excellent benefits · Location: Belfast, Northern Island with flexible workin ...
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M&e Manager
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Newman Stewart Ireland, United Kingdom**M&E Manager** · **€90,000-€120,000 + Benefits** · **Republic of Ireland** · **Our client** · Our client is a leading general building contractors with multiple offices across Ireland and the UK. · They are known for their vast portfolio spanning from traditional building contra ...
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P3o Assurance Manager
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Senior Programme Manager PMO
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Senior Facilities Manager Single Site
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Financial Controller
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Programmatic Trader
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Senior Quantity Surveyor
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Quality Engineer
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Financial Business Partner
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Technical Manager
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7twenty Professional Search Northern Ireland, United Kingdom7twenty Professional Search is partnering with one of Northern Ireland's Top 100 Companies and one of Ireland's most successful independent manufacturing companies to appoint a Technical Manager based in Co. Antrim. With a solid reputation in its chosenmarkets, our client is gear ...
Quality Management Lead H/F - Northern Ireland, United Kingdom - Team Horizon
Description
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.
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.
