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Title:  Micro/Particle Laboratory Supervisor

Requisition ID:  42643
Date:  Nov 25, 2021
Location: 

Waterford, Munster, IE

Department:  Laboratory
Description: 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

 

 

Job Summary:

Plan, manage and supervises the activities of the laboratory and its analysts. Perform all microbiological /particle testing and ensure their delivery in an accurate and timely fashion using proper cGMP & safety precautions. Provide day to day technical and administrative support.

 

Essential Duties and Responsibilities:

  • Supporting the Laboratory Manager in generating and executing on Instrument Qualification protocols or test method transfer protocols, generating standard operating instructions or implementing workflows.
  • Supervising a group of Analysts, with the goal of performing all microbiological/particle testing that is required to support plant operations. This includes batch release testing as well as testing of incoming materials such as Sterilisable Bags or raw materials.
  • Organization of the environmental monitoring of production areas, pharmaceutical water systems and microbial monitoring of Production Operators. This includes initiating monitoring excursion and supporting the site regarding risk analysis, root cause analysis and identification of appropriate CAPA
  • Implementing processes and procedures to ensure on-time delivery of testing in compliance with cGMP, the relevant Regulatory Guidelines/Industry Standards and the relevant local and global Safety Guidelines.
  • Guiding customer audits in the  microbiology/particle testing laboratory area.
  • Investigating OOS/OOT results and implementing CAPAs related to microbiology/particle testing.
  • Executing/supporting qualification/validation activities within the laboratory, production clean rooms or water systems, e.g.  (re-)validation of Endotoxin removal processes
  • Supporting other functions (e.g. R&D, TCS, process engineering) as a Subject Matter Expert
  • Contributing to the harmonization of test methods, equipment, infrastructure, etc. based on the strategy of the global West laboratory organization.
  • Developing/implementing new test methods in alignment with global West laboratory strategy.
  • Approval of Documents in the Laboratory Supervisor’s (Chem/Analytical) absence: SOIs, ESOPs, EWIs, Attachments, Protocols, Reports, Strategy documents, Risk Assessments, OOS investigations, Deviations.
  1. Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  2. Compliance to all local site company policies, procedures and corporate policies.
  3. Act in accordance with the company’s Guiding principles and adherence to the Corporate Code of Conduct.
  4. Perform additional duties at the request of the direct supervisor.

 

Basic Qualifications: 

•       Degree in Microbiology

 

Preferred Knowledge, Skills and Abilities:

  • 5+ year experience is a similar role (micro biology testing) within the pharmaceutical / medical devices / manufacturing industry.
  • Experience in a cGMP environment.
  • Strong competence in IT
  • Good verbal and written communication skills
  • Excellent interpersonal skills with the ability to work with all levels within the organisation.
  • Team player.
  • Structured way of working & strong organisational skills
  • Ability to interact with suppliers, customers and external contractors.
  • Fluent in English

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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