Senior Quality Specialist
7 months ago
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.
Summary:
The primary responsibilities of the Senior Quality Specialist involve Systems over-sight customer focus within our all Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. For coordinating the necessary activities for ensuring the timely closure of internal/external quality issues / projects and to coordinate / drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. Reports directly to the Quality Compliance Manager.
Requirements:
Must have a third level qualification in Engineering/Quality/Science. Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience. Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment. A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4/ EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage. Knowledge of and experience in setting up and maintaining an effective QMS. Accredited lead auditor against recognised quality standards in support of internal and supplier audits Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971. Experience of hosting regulatory audits from either the European or US authorities Must have excellent communication and written skills Must be able to work in a fast paced environment. Must be able to travel as required by the position. Must be able to organize and prioritize tasks; must be detail orientated and self-motivated. An ability to collaborate across functional lines and work effectively in a team environment Must be able to work independently on own projects while working concurrently with all departmentsEssential Duties and Responsibilities:
Understand and ensure compliance with internal procedures and external global regulatory requirements. Lead investigations related to Quality System related issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. Support trend analysis and issuance of key reports to relevant departments. Support responses to Competent Authority queries. Support risk management, risk analysis and hazard analysis associated with complaint/post-market information. Actively participate as Lead Auditor in Internal & External Audit Schedule. Support of third party audits, control room set-up and management of general audit readiness throughout the business. Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory. DHR review of Medical Device to be conducted within the QMS. Responsible for the scheduling, data collection and co-presenting Management Review. Support and drive the improvement and culture for data integrity. Coach and drive a culture of compliance and continuous improvement. Develop processes and systems in line with best industry practice. Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level. Support regulatory submissions as required. Interface with other departments on a regular basis to ensure adherence to West QMS, drive quality improvements and compile/relay trends and occurrences throughout the year. Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all site Environmental, Health and Safety requirements, training and regulations. Compliance to all local site company policies, procedures and corporate policies. Perform additional duties at the request of the direct supervisor.Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates
Job Title: Quality Specialist Complaints and/or Quality Systems Co-ordinator
(for Routine Quality System responsibilities)
Job Title: Quality Compliance Manager & Quality Manager
(for all responsibilities outside of routine Quality System responsibilities)
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