Quality Assurance Manager - Validation
QUALITY ASSURANCE SYSTEMS & VALIDATION
Location: Athlone
Job type: 12 Month Fixed Term with option to Extend
Salary: Competitive / Based On Experience
Discipline: Active Pharmaceutical Ingredients (cGMP)
Reference: DUN_2301
Position Title: Senior QA Systems and Validation Manager
Reports to: Head of Quality
The Location:
The new API manufacturing site is within Arbutus Innovation Centre, a pharmaceutical incubator located in Monksland, on the west side of Athlone.
Introduction
Join an exciting new Irish Company researching and producing speciality Active Pharmaceutical Ingredients for global distribution. We are seeking to have an energetic QA professional with a passion for validation to join our team. You will be joining a small, energetic team that works closely across departments with visibility across the entire operations.
Working with this 100% Irish pharmaceutical start-up will enable you to experience the build-out of a green-field site and the development and export of new, exciting GMP APIs.
You will be responsible for ensuring compliance with regulatory requirements and maintaining validation programs in accordance with current Good Manufacturing Practices (cGMP) guidelines. You will support general QA activities, with a particular focus on validation activities such as protocol development, execution, and reporting.
You will provide oversight and support for quality systems related to validation activities, as well as review and approve validation documents and protocols. In addition, you will be responsible for performing QA reviews and approval of validation lifecycle documentation.
Your knowledge and skills will contribute towards the overall goals and objectives of the QA team and company wide goals. Your focus and ability to meet team targets will help in completing critical deliverables.
Key Responsibilities:
Work with external experts and consultants to develop the Cleaning/Validation Master Plan to support the multi-product API manufacturing facility
Support the development, implementation and maintenance of the validation program in accordance with cGMP guidelines and company policies
Write and review validation protocols, reports, and other technical documents including cleaning (CIP) cycles/methods , equipment trains, parts washers and supporting process equipment.
Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required.
Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
Provide guidance and support to cross-functional teams for validation activities
Monitor and ensure the timely execution of validation activities, including documentation and testing
Ensure compliance with regulatory requirements and company policies related to validation activities
Provide oversight and support for quality systems related to validation activities, including change control, deviations, and CAPAs
Participate in internal and external audits and inspections related to validation activities
Perform QA review and approval of validation lifecycle documentation, including cleaning validation systems
Participate in the development and approval of risk assessments relating to validation activities
Assess a wide range of Change Control activities to determine potential Quality and cGMP impacts.
Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
Develop and maintain cleaning validation programs and protocols
Provide oversight and support for quality systems related to cleaning validation activities, including change control, deviations, and CAPAs
Support the QA and QC teams during periods of high demand
Carry out general QA activities and support QA/QC/Production with documentation and quality design
Qualifications and Experience:
Bachelor's or Master’s degree in a scientific, quality or engineering field
Minimum of 5 years of experience in quality assurance and/or 3 years validation in pharmaceutical manufacturing GMP
Very strong knowledge of cGMP guidelines and regulations
Experience with validation activities such as protocol development, execution, and reporting
Extremely strong technical writing and communication skills
Ability to work collaboratively with cross-functional teams
Skills and Competencies:
Attention to detail and ability to work independently
Strong problem-solving and critical thinking skills
Ability to prioritize and manage multiple projects simultaneously
Strong communication and interpersonal skills
Very strong computer skills, including proficiency with Microsoft Office
Other Factors:
The role may require very occasional travel for training or audit purposes
The individual must be able to work in a manufacturing environment, including wearing appropriate personal protective equipment
The work schedule may require occasional off-hours or weekend work, as needed to support validation activities and duties
What We Offer
Bonus Schemes
VHI Healthcare
Flexible working
Wellness Program
Great working culture
Opportunity for fast career progression
Modern Processes, equipment, management mindset
Additional Information
To be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position.
Interested candidates should submit an updated CV.
Please click the link below to apply or alternatively send an up to date CV and cover letter to careers@arbutus.ie
Job Type: Full-time, Permanent
Salary: €48,701.30-€72,404.94 per year
Benefits:
Additional leave
Company events
Flexitime
On-site parking
Private dental insurance
Private medical insurance
Sick pay
Wellness program
Schedule:
Flexitime
Monday to Friday
No weekends
Ability to commute/relocate:
Daneswell Business Park, Athlone, CO. Westmeath: reliably commute or plan to relocate before starting work (required)
Application question(s):
How many years Experience do you have working in a QA department in a GMP environment?
Language:
Fluent English (required)
Work Location: In person
Reference ID: DUN_2301
Expected start date: 20/05/2023
Competitive Salary & Benefits:
Interested candidates should submit an updated CV and cover letter to: