CAPA & Validation Manager page is loaded
CAPA & Validation Manager
Apply locations Ireland - Cootehill time type Full time posted on Posted 3 Days Ago job requisition id 31109675
JOB DESCRIPTION:
24-month FTC
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, nutritionals and branded generic medicines. Our 113,000 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 nutritionals products. In Ireland, Abbott employs about 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.
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.
* Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required.
* This manager is responsible for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
* Manage and lead a team consisting of CAPA and Validation Engineers. Ensure resources are managed appropriately and in accordance with Abbott and legislative standards.
* The CAPA manager will lead investigations involving High Impact ER’s and work closely with plant SME’s to ensure a thorough investigation is carried out identifying root cause.
* This function must ensure preventative actions put in place are effective and effectivity reports reviewed and tracked accordingly.
* The CAPA manager must maintain and report monthly metrics to the plant with regard to plant Quality metrics.
* The function leads the Monthly and Quarterly Management Review and ensures all information is tracked and collated accordingly for an effective forum.
* Responsible for leading the weekly QA/CAPA meeting and ensuring all SME’s are engaged in the CAPA process.
* This function will maintain very good communication with Division and Corporate colleagues.
* The role will identify and develop where necessary appropriate training for the facilities with regard to CAPA systems.
* This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made.
* 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
* Responsible for the overall CAPA management system for the Cootehill facility. Ensure resources are identified to ensure accurate and timely reporting of metrics.
* This function plays a key role in investigation of high impact ER’s to ensure thorough investigation and root cause is identified.
Supervisory/Management Responsibilities
* The CAPA and Validation Manager has responsibility for the supervision of the Validation Engineer and the CAPA & Metrics Specialist in the Quality Department.
* Additionally, the position will require a managerial role in the following areas:
o Contacts with all levels of management within the plant.
o Contacts with Abbott personnel in other affiliates especially in Quality, Engineering, Regulatory, Technical, Manufacturing, and Materials.
This role plays a vital role in leading the department managers and SME’s to ensure a strong and effective system exists.
Education Required
* A Bachelor of Food Science/Chemistry/Quality or a Third level qualification in a related discipline.
Knowledge
* Very good understanding of the manufacturing process.
* Strong knowledge and experience in analytical techniques and methods used.
* Excellent interpersonal skills and management skills.
o Ability to:
o Communicate with all levels of the organization.
o Communicate effectively with cross-functional team.
o Recognize and reward effort.
o Resolve conflict constructively.
o Seek feedback.
Accountability / Scope
* This function will have responsibility to ensure the CAPA system is managed effectively and all plant investigations are carried out fully and appropriately. The impact of ineffective reporting may have implications on plant operations and quality of Abbott product.
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
About Us
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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