Laboratory Projects Manager

Job description

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Nutrition Division Cootehill Cavan

Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow-on formulae under the brand name of “Gain”. The essential ingredient is liquid skim-milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, Southeast Asia, the Middle East, Latin America and Canada.

Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.

Primary Function / Goals / Objectives

·  Follow all Environmental, Health and Safety Rules and Regulations in the plant.
·  Report any current or potential hazards to your manager immediately.
·  The laboratory technician must wear the correct Personal Protective Equipment (P.P.E.) at all times for the work they are carrying out.  This will protect from chemical hazards and general laboratory hazards.  Appropriate controls such as fume hoods and ventilation must also be utilised as necessary. Furthermore, the appropriate SOP or test method must be consulted as required.
·  This job function has the responsibility to be part of a team that is responsible for laboratory projects relating to continuous improvement, business continuity and compliance across three laboratories Analytical, Microbiology and Incoming Quality Assurance Laboratories.
·  This job function will include completion of necessary validation documentation and assist in the execution of validation activities.
·  Activities include installation, qualification and validation of laboratory equipment, software and test methods within the Quality Assurance Department.
·  This function has the responsibility for reviewing all SOP’s for any job task he/she may carry out and must ensure that he/she fully understands and adheres to the SOP.
·  Participate in plant projects as requested.
·  Conduct compliance audits and walk-downs and complete necessary follow-up reports.
·  Support QA (M-FILES) through which Validation Change Control is documented.  This also involves the development and support of plant SME’s and general users.
·  Participate in internal audits.
·  Support QA team with internal and external audits (including pre-audit preparation) surrounding the validation processes.  This Job function will change when GMP, EHS, Quality and Technical/New Equipment Procedures, SOP’s and test methods are updated.
·  This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises. 

Major Responsibilities

·  The manager has the responsibility to participate in laboratory projects such as the validation of new equipment, the qualification of new test methods and laboratory compliance improvement projects for the Analytical, Microbiology and Incoming Quality Assurance Laboratories.
·  The employee will also carry out test method transfer activities for the Analytical/ Micro Laboratories in Cootehill.
·  The job function has the responsibility for reviewing and ensuring compliance to test methods and procedures to any task the employee may carry out and ensure she/ he fully understands and adheres to procedures.
·  Manage the financial budget requirement for laboratory validation projects.
·  Align lab validation resources as per project requirements.  

Supervisory/Management Responsibilities  

·  Be responsible for a team Laboratory Validation Technicians / Engineers
·  Raise analytical laboratory compliance through GLP training, data integrity improvements and audit preparation improvements.
·  Address the Data Integrity noncompliance in the Analytical Laboratory by closing FDA remediation plan as per agreed actions.
·  Source, purchase, validate and implement new laboratory equipment as per agreed implementation plan and through Validation Review Board Lab meetings.
·  Co-ordinate method transfers with Division R & S and with the laboratory technicians and ensure all training is completed.

Education Required

·  Degree/Diploma or Cert in Food Science or equivalent scientific discipline.

Knowledge

·  Ability to communicate changes in project schedules to key stakeholders and projects team when required.
·  It is an advantage to have knowledge on Validation Policies or FDA regulations in relation to validation.
·  Excellent critical thinking/analytical and problem-solving skills.
·  Excellent interpersonal and computer skills and the ability to work as an effective member of a high-performance team with ability work independently.
·  Translate technical information and requirements into qualification/validation test design.
·  Experience with various laboratory equipment a plus.

Accountability / Scope

·  Validation of laboratory test equipment is critical to the overall quality of the product.  Errors in validation documentation could potentially lead to a rejected batch or distressed inventory.    

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ANSC Nutrition Supply Chain

        

LOCATION:

Ireland > Cootehill : Dromore West

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Chsal39 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable