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Quality Manager
1 week ago
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Title: Quality ManagerRequisition ID: 68298
Date: Jan 13, 2025
Location: Dublin, Leinster, IE
Department: Quality
Description:
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century.
Our story began when Herman O.
West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2.
Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.
A name started our story.
How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development.
Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work.
And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary: Reporting to the Director of Quality to ensure that all pharmaceutical products manufactured or distributed by the company comply with global and local regulatory requirements, company standards, and customer expectations.
Key Responsibilities: Quality Systems Management: Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.Oversee the management of SOPs, Work Instructions, and other quality-related documentation.Regulatory Compliance: Ensure that all products and processes comply with relevant regulations and guidelines (e.g., FDA, EMA, MHRA).Stay updated with changes in regulatory requirements and ensure timely implementation of necessary changes.Audits and Inspections: Lead internal audits and participate in external audits and regulatory inspections.Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.Training and Development: Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.Monitor the effectiveness of training programs and maintain training records.Quality Control: Oversee the quality control processes, including raw material testing, in-process monitoring, and final product testing.Ensure that all quality control activities are documented and carried out in accordance with established procedures.Deviation and Change Control Management: Manage and investigate deviations, non-conformances, and product complaints.Oversee the change control process to ensure proper evaluation, approval, and implementation of changes in procedures, equipment, or processes.Product Release: Collaborate with the Qualified Person (QP) to ensure that batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.Continuous Improvement: Promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions.Use quality metrics and data analysis to drive process improvements and enhance product quality.Supplier Quality Management: Evaluate and qualify suppliers and contractors to ensure they meet the company's quality standards.Manage supplier audits and assessments to maintain a high level of quality throughout the supply chain.Required Qualifications: Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.A minimum of 5 years of experience in quality management within the pharmaceutical industry.In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.Experience with QMS implementation and management.Skills and Competencies: Strong leadership and team management skills.Excellent communication and interpersonal skills.Attention to detail and strong analytical skills.Ability to handle multiple tasks and prioritize effectively.Proficiency in risk management and problem-solving.Competency in using quality management software and tools.Preferred Qualifications: Certification in quality management (e.g., Certified Quality Auditor (CQA), Certified Quality Manager (CQM)).Experience with Lean, Six Sigma, or other continuous improvement methodologies.Additional Information: Availability for travel as needed.Ability to work under pressure and meet tight deadlines.Commitment to maintaining the highest standards of quality and compliance.Physical and Mental Requirements: Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.Delegation of Duties: When absent from the site duties and responsibilities will be delegated to the following designates:
Senior Quality EngineerQuality DirectorWest 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 ******.
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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