Description:
Responsibility for compliance with the Quality and Regulatory requirements for combination medicinal and device products assembled and packed by West CM (Dublin). This role is also responsible for overseeing the compiling of technical and quality documents in support of submissions to the relevant authorities, for obtaining and maintaining the required medicinal product manufacturing authorisations. Reports directly to the Snr. Quality Manager.
Essential Duties And Responsibilities
- Reporting to the Snr. Quality Manager of West CM (Dublin), this role will be responsible for the upgrading and maintaining of West CM (Dublin)’s quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement, this includes the establishment, maintenance and continuous improvement of West CM (Dublin)’s quality systems, procedures, and policies.
- Manage the Quality Compliance team, 1:1 meetings and Training & Development Plan for Reports
- Provide regulatory guidance to the business including regulatory training, keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to West CM (Dublin) and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feed-back to relevant stakeholders
- Liaise with Customers and regulatory agencies on behalf of West CM (Dublin).
- Supply Chain QA responsible for the review and approval of all Suppliers on the AVL and their ongoing control through Supplier Corrective Action Report management, vendor rating and audit management.
- Develop, lead, and maintain a comprehensive audit readiness program to ensure internal and external compliance
- Drive standardization of West CM (Dublin) QMS in line with our parent company West Pharmaceutical Services
- Develop reports / presentations on the status of the compliance program for West CM (Dublin) senior management team and the wider West Pharmaceutical Services colleagues.
- Embed QMS management principles in the organisation & drive continuous improvement
- Liaise with the QP on performance of the QMS and emerging quality trends and risks.
- Conduct various trend analyses to identify short and long-range patterns so that recommendations can be made to effect continuous improvement necessary to satisfy customer requirements and drive improvements of West CM (Dublin) QMS
- Work closely with the NPI and Operations Department to ensure that programs are introduced to West in a manner that complies with the appropriate regulatory requirements, customer specification and consistent with West Quality Management Systems (QMS)
- Lead continuous improvement initiatives to ‘challenge’ the quality systems process with respect to compliance / value add.
- 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.
- Other duties as assigned
Basic Qualifications
- Minimum requirement is a degree programme in either pharmacy, chemistry, biology,
microbiology or equivalent
- At least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).