- Experience Level
- Experienced (non-manager)
Our newly formed Quality Assurance Manager role is responsible for the implementation and maintenance of the quality management system (including QA distribution and for commercial activities), proactively identifying and solving compliance issues in alignment with corporate quality functions and acting as professional quality advisor to key stakeholders in UK. Act as Responsible person to be named on the Wholesale Dealer’s Licence. Act as Responsible Person for Imports (RPi) as defined by MHRA to allow import of QP certified product in to the UK post Brexit. To take on duties as defined by the MDR 2017/745 and those defined by the MDR 2002 as amended including some of those required for the UKRP entity for medical devices.
- Responsibility of implementation and maintenance of QMS e.g.:
- Nonconformity Handling, CAPA’s, and Internal Complaints
- Change Control
- Contracts & Quality Agreements
- Responsible for overseeing quality compliance including quality management of electronic records and electronic signatures
- Document Control
- QMS Management and administration
- Training Management
- Archiving/Record Management
- Quality Management Review
- Maintenance of all relevant and necessary licenses
- Communication with UK Health Authorities
- Planning and performing self-inspections and ensuring CAPAs are effective and completed in a timely manner;
- Qualification of suppliers and customers;
- Involvement and supporting audits and inspections
- Release/non-release of Returned of goods
- Involvement in recall procedures and execution
- Control and preparation of PQRs
- Reporting of QPIs and site performance as needed on monthly basis
- Management of 3 PLs / distribution providers for signing agreements, audits & ensuring quality compliance
- MDR, Brexit & EU transition including, drafting SOPs, implementing and undertaking importer and distributor requirements.
Qualifications & Experience
- Degree in Pharmacy, Chemistry, Biology or equivalent with professional body membership
- Proven experience in performing the functions of an RP on a Wholesale Dealer’s Licence, or a Qualified Person named on the QP register.
- Significant experience in the pharmaceutical industry, with solid knowledge and experience in quality and compliance for medicines and medical devices (ISO 13485 and / or ISO 9001 would be useful);
- Experience of auditing
- Hands-on experience of implementing/managing quality systems in a GxP environment
- Fluent in English (oral and written)
- Ability to communicate proficiently with all levels of the organization and its clients
- Experience in Affiliate Quality Operations is a plus
- Required to be a pro-active, self-assured professional with high personal integrity and accountability
- Ability for some occasional (international) travel – post Covid
Working for Bausch & Lomb UK
You will enjoy a good benefits package that includes generous pension, medical cover, 25 days holiday, life assurance and income protection. We have additional benefits you can purchase such as dental and travel insurance and extra days holiday subject to conditions.
Join the Movement
We employ dedicated and innovated team members who are driven to solve problems. We recognize that our team members are essential to our future. It is our goal to make everyone feel respected and equally appreciated so we are all dedicated and committed to the same cause. Our team members enjoy a dynamic work environment that encourages both professional evolution and personal growth. Each day you spend at Bausch + Lomb, you have the satisfaction of knowing that you are working with dedicated individuals who share a common vision of constant innovation. To ensure that we achieve our goals, our team members are continually learning more about their fields of expertise. We are proud to facilitate this development by providing internal and external professional development opportunities. This commitment to growth helps drive our Business and our employees.
So if you want to join our team to help the world to see better, in order to live better, please Apply Now.