• integrity without compromise

+353 91 574355 services@cls.ie

RECRUITMENT

SENIOR ANALYTICAL CHEMIST

Reporting to: Quality Manager

EXPERIENCE / QUALIFICATIONS
  • Must have a minimum of Three years industrial experience in a GMP regulated QC chemistry laboratory.
  • A degree in Analytical Chemistry, Pharmaceutical Chemistry or other related qualification is required.
 
DUTIES & RESPONSIBILITIES
  • Ensuring that all operations within the chemistry laboratory are performed in accordance with applicable regulations, standards and guidelines.
  • Selection, installation, qualification and ongoing maintenance of laboratory equipment in accordance with the CLS laboratory quality system and GMP.
  • Generation of documentation to support test method transfers from clients.
  • Execution of testing as per approved protocols and test method etc.
  • Write up of all test results as per GMP and in accordance with the Quality System including Out of Specification results and Laboratory Deviations.
  • Review and approval of Laboratory quality records as per GMP and in accordance with the Quality System e.g. Out of specification results, laboratory deviations etc.
  • Training of junior staff.
  • Participation in self inspections audits.
  • Communicate with customers in relation to technical queries, forecasting etc.
  • GMP review of Laboratory log books.
  • Participate in Laboratory audits e.g. Regulatory Customer.
  • Interpret analytical results and resolve technical and/or operational problems and provide technical advice and support to all technicians/analysts.
  • Prepare, review and revise, as required, SOPs and specifications. Initiate and review out of specification and deviation reports, protocols and other appropriate documentation for proper functioning of the lab operation.
  • Support and manage projects to be on time, within budget and to meet business requirements.
  • Ensure the validation status for all test methods and laboratory equipment is compliant with regulatory requirements and internal procedures.

APPLICATION

Please email your application letter and C.V. to Miriam Murphy: mmurphy@cls.ie

CLOSING DATE

12th January 2015
 


DEPUTY QUALITY MANAGER FOR MICROBIOLOGICAL LAB

Vacancy in our microbiology laboratory based in Galway. The role is full time and permanent following an initial 6 months probation period.

 

THE ROLE:

The complete responsibility for overseeing compliance including the upkeep and maintenance of cGMP, FDA and ISO 17025 reporting to the Quality Manager.

 

EXPERIENCE / QUALIFICATIONS:
  • Minimum of a Level 7 degree in Microbiology or related qualification.
  • 5yrs + experience within Pharmaceutical GMP lab environment
  • Minimum 2yrs experience within Quality role of Pharmaceutical GMP lab environment
  • Highly organised
  • A professional, pro-active approach to work, combined with strong leadership skills and an ability to work efficiently under pressure
  • Must have good written and verbal communication skills
  • Be capable of working on own initiative, motivate personnel to achieve high quality and compliance standards
  • Ability to critically review analytical data, processing excellent attention to detail is a must
  • Experience in method development and validation
 
DESIRABLE:
  • Good attention to detail
  • Good working knowledge of Microsoft Office: Excel, Word, PowerPoint
  • Highly motivated
  • Full driving licence
 
RESPONSIBILITIES:
  • Accountable for frontline quality management of the Microbiological Laboratory activities.
  • Overall responsibility for the maintenance of cGMP, FDA and ISO17025 quality systems within the Microbiological Department
  • Preparing for and facilitating all compliance inspections, customer and quality audits for the Micro Laboratory
  • Ensuring that all quality systems within the department are adhered to on a daily basis, GMP and ISO 17025. Initiating actions to prevent the occurrence of quality system errors and non conformances
  • Dealing with CAPAs, lab deviations and out of specification investigations for the Microbiological Lab
  • Participating in creating, reviewing updating and approving documentation and test records
  • Participating in methods development and method validation
  • Ensuring the integrity of results delivered to and reported to clients
  • Ensuring equipment is compliant to IQ, OQ and PQ requirements and is calibrated/ verified on an annual basis
  • Reporting on the performance of the quality systems within the Micro Lab to management.
  • Ensuring that trend analysis of proficiency testing, IQC, EM are completed on a regular basis
  • Ability to liaise with customers to interpret results and problem solve
 
APPLICATION:

Suitable applicants are invited to email their application with CV to aodonnell@cls.ie Please quote ref: MP-MO-0914 in your application email.

 

EXPERIENCED PHARMACEUTICAL CHEMIST

 
EXPERIENCE / QUALIFICATIONS:
  • Must have a minimum of Two to Three years industrial experience in a GMP regulated QC chemistry laboratory.
  • A degree in analytical chemistry, pharmaceutical chemistry or other related qualification is required.
 
THE CANDIDATE:
  • Must have 2+ years experience on HPLC and familiar & fluent with Empower software.
  • Strong documentation skills are required.
  • Must have strong time management skills.
  • Must possess key competencies: Team Work, Flexibility, Planning/Organisation, Problem Solving, and Communication.
  • Experience with regulatory inspections and interacting with inspectors.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral) skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • A strong team player is essential.
  • Must be motivated, focused and technically strong.
 
SALARY:

A good remuneration package is available for the suitable candidate.

 
APPLICATION:

Suitable applicants are invited to email their application with CV to marcryan@cls.ie. Please quote EPC100114 in your application email.

 

VALIDATION CHEMIST

 
QUALIFICATIONS / EXPERIENCE REQUIRED:
  • Must have a minimum of three years industrial experience in a 17025 accredited laboratory.
  • A degree in analytical chemistry, organic chemistry or other related qualification is required. 
 
The Candidate:
  • A strong track record in the validation of chromatography techniques
  • Have technical knowledge in the development and validation of analytical methods as per ICH guidelines
  • Possess the ability to troubleshoot instrumentation/methodology/data validation issues systematically and utilise strong technical knowledge in resolving issues
  • Must be motivated, focused and technically strong

Reporting to: Quality Manager

Salary: A good remuneration package is available for the suitable candidate.

Please send applications with cover letter tohr@cls.ie